Class IILevothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-442026-04-01
Subpotent Drug
Recalling firm: MACLEODS PHARMA USA, INC
Class IILevothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-172025-07-23
Subpotent Drug: Assay below the approved specification
Recalling firm: ACCORD HEALTHCARE, INC.
Class IILevothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-152025-07-23
Subpotent Drug: Assay below the approved specification
Recalling firm: ACCORD HEALTHCARE, INC.
Class IILevothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-152025-07-23
Subpotent Drug: Assay below the approved specification
Recalling firm: ACCORD HEALTHCARE, INC.
Class IILevothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-450-172025-05-07
Subpotent
Recalling firm: ACCORD HEALTHCARE, INC.
Class IILevothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.2025-03-26
Super-Potent Drug: Out of specification potency results were obtained.
Recalling firm: Mylan Institutional, Inc.
Class IILevothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-032025-01-08
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Recalling firm: Lupin Pharmaceuticals Inc.
Class IILevothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.2024-12-18
Superpotent Drug and Subpotent Drug: potency failures obtained
Recalling firm: Viatris Inc
Class IILevothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.2024-12-18
Superpotent Drug and Subpotent Drug: potency failures obtained
Recalling firm: Viatris Inc
Class IILevothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-443-202024-12-18
Subpotent and Superpotent Drug
Recalling firm: Mylan Institutional, Inc.
Class IILevothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-040-202024-12-18
Subpotent and Superpotent Drug
Recalling firm: Mylan Institutional, Inc.
Class IILevothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.2024-12-18
Superpotent Drug and Subpotent Drug: potency failures obtained
Recalling firm: Viatris Inc
Class IILevothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-442-202024-12-18
Subpotent and Superpotent Drug
Recalling firm: Mylan Institutional, Inc.
Class IILevothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-445-202024-12-18
Subpotent and Superpotent Drug
Recalling firm: Mylan Institutional, Inc.
Class IILevothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-039-202024-12-18
Subpotent and Superpotent Drug
Recalling firm: Mylan Institutional, Inc.
Class IILevothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.2024-12-18
Superpotent Drug and Subpotent Drug: potency failures obtained
Recalling firm: Viatris Inc
Class IILevothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.2024-12-18
Superpotent Drug and Subpotent Drug: potency failures obtained
Recalling firm: Viatris Inc
Class IILevothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 42292-041-202024-12-18
Subpotent and Superpotent Drug
Recalling firm: Mylan Institutional, Inc.
Class IILevothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-172024-12-11
Subpotent drug
Recalling firm: ACCORD HEALTHCARE, INC.
Class IILevothyroxine Sodium Tablets, USP 112 mcg, 90 tablets per bottle, Rx Only, Manufactured by Lloyd Inc., Shenandoah, IA, 51601, Distributed by: Alvogen Inc, Pine Brook, NJ 07058, NDC 47781-654-90.2023-03-08
Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Recalling firm: Alvogen, Inc
Class IITIROSINT - SOL (levothyroxine sodium) Oral Solution, 200 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0160-52023-03-01
Subpotent Drug
Recalling firm: IBSA PHARMA INC
Class IITIROSINT - SOL (levothyroxine sodium) Oral Solution, 137 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0145-52023-03-01
Subpotent Drug
Recalling firm: IBSA PHARMA INC
Class IITIROSINT - SOL (levothyroxine sodium) Oral Solution, 75 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0120-52023-03-01
Subpotent Drug
Recalling firm: IBSA PHARMA INC
Class IITIROSINT - SOL (levothyroxine sodium) Oral Solution, 150 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0150-52023-03-01
Subpotent Drug
Recalling firm: IBSA PHARMA INC
Class IITIROSINT - SOL (levothyroxine sodium) Oral Solution, 62.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0117-52023-03-01
Subpotent Drug
Recalling firm: IBSA PHARMA INC
Class IITIROSINT - SOL (levothyroxine sodium) Oral Solution, 175 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0155-52023-03-01
Subpotent Drug
Recalling firm: IBSA PHARMA INC
Class IITIROSINT - SOL (levothyroxine sodium) Oral Solution, 112 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0135-52023-03-01
Subpotent Drug
Recalling firm: IBSA PHARMA INC
Class IITIROSINT - SOL (levothyroxine sodium) Oral Solution, 37.5 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0112-52023-03-01
Subpotent Drug
Recalling firm: IBSA PHARMA INC
Class IILEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 233202023-02-22
Lack of sterility assurance
Recalling firm: Sentara Infusion Services
Class INP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300052021-06-02
Subpotent Drug
Recalling firm: Acella Pharmaceuticals, LLC
Class INP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 42192-329-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 300052021-06-02
Subpotent Drug
Recalling firm: Acella Pharmaceuticals, LLC
Class INP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-330-012021-06-02
Subpotent Drug
Recalling firm: Acella Pharmaceuticals, LLC
Class INP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-012020-10-28
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
Recalling firm: Acella Pharmaceuticals, LLC
Class IINature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottles (NDC 68788-7604-09), b) 100-count tablets (NDC 68788-7604-01), Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc.2020-09-30
CGMP Deviations
Recalling firm: Preferred Pharmaceuticals, Inc.
Class IINature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-9283-012020-09-30
CGMP Deviations
Recalling firm: Preferred Pharmaceuticals, Inc.
Class IINature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg, 90-count bottles, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-7605-092020-09-30
CGMP Deviations
Recalling firm: Preferred Pharmaceuticals, Inc.
Class IINature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg], 1.75 Grain (113.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3307-4; b) 60-count bottles, NDC 64727-3307-5; c) 90-count bottles, NDC 64727-3307-6; d) 100-count bottles, NDC 64727-3307-1; and e) 1,000-count bottles, NDC 64727-3307-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.2020-09-23
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Recalling firm: RLC Labs Inc.
Class IINature-Throid, Thyroid USP [liothyronine (T3) 11.25 mcg and levothyroxine (T4) 47.5 mcg], 1.25 Grain (81.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3303-4; b) 60-count bottles, NDC 64727-3303-5; c) 90-count bottles, NDC 64727-3303-6; d) 100-count bottles, NDC 64727-3303-1; e) 1,000-count bottles, NDC 64727-3303-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.2020-09-23
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Recalling firm: RLC Labs Inc.
Class IINature-Throid, Thyroid USP [liothyronine (T3) 6.75 mcg and levothyroxine (T4) 28.5 mcg], 3/4 Grain (48.75 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3302-4; b) 60-count bottles, NDC 64727-3302-5; c) 90-count bottles, NDC 64727-3302-6; d) 100-count bottles, NDC 64727-3302-1; and e) 1,000-count bottles, NDC 64727-3302-2; Rx Only, Manufactured by: RLC Labs Phoenix, AZ 85034.2020-09-23
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Recalling firm: RLC Labs Inc.
Class IINature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg], 1/2 Grain (32.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3299-4; b) 60-count bottles, NDC 64727-3299-5; c) 90-count bottles, NDC 64727-3299-6; d) 100-count bottles, NDC 64727-3299-1; and e) 1000-count bottles, NDC 64727-3299-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.2020-09-23
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Recalling firm: RLC Labs Inc.
Class IINature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg], 2.5 Grain (162.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3310-4; b) 60-count bottles, NDC 64727-3310-5; c) 90-count bottles, NDC 64727-3310-6; d) 100-count bottles, NDC 64727-3310-1; and e) 1,000-count bottles, NDC 64727-3310-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.2020-09-23
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Recalling firm: RLC Labs Inc.
Class INature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg], 100-count bottles, Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3303-12020-09-23
Subpotent Drug: FDA analysis found product to be subpotent
Recalling firm: RLC Labs Inc.
Class IINature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg], 2.25 Grain (146.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3309-4; b) 60-count bottles, NDC 64727-3309-5; c) 90-count bottles, NDC 64727-3309-6; d) 100-count bottles, NDC 64727-3309-1; and e) 1,000-count bottles, NDC 64727-3309-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.2020-09-23
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Recalling firm: RLC Labs Inc.
Class INature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 30-count bottles (NDC 64727-3305-4), b) 60-count bottles (NDC 64727-3305-5), c) 90-count bottles (NDC 64727-3305-6), and 100-count bottles (NDC 64727-3305-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3305-12020-09-23
Subpotent Drug: FDA analysis found product to be subpotent
Recalling firm: RLC Labs Inc.
Class IINature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg], 1 Grain (65 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3300-4; b) 60-count bottles, NDC 64727-3300-5; c) 90-count bottles, NDC 64727-3300-6; d) 100-count bottles, NDC 64727-3300-1; and e) 1,000-count bottles, NDC 64727-3300-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.2020-09-23
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Recalling firm: RLC Labs Inc.
Class IWP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 30-count bottles (NDC 64727-5550-4), b) 90-count bottles (NDC 64727-5550-6), c) 100-count bottles (NDC 64727-5550-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 850242020-09-23
Subpotent Drug: FDA analysis found product to be subpotent
Recalling firm: RLC Labs Inc.
Class IINature-Throid, Thyroid USP [liothyronine (T3) 13.5 mcg and levothyroxine (T4) 57 mcg], 1.5 Grain (97.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3305-4; b) 60-count bottles, NDC 64727-3305-5; c) 90-count bottles, NDC 64727-3305-6; d) 100-count bottles, NDC 64727-3305-1; and e) 1,000-count bottles, NDC 64727-3305-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.2020-09-23
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Recalling firm: RLC Labs Inc.
Class IIWP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-5450-4; b) 60-count bottles, NDC 64727-5450-5; c) 90-count bottles, NDC 64727-5450-6; d) 100-count bottles, NDC 64727-5450-1; and e) 1,000-count bottles, NDC 64727-5450-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.2020-09-23
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Recalling firm: RLC Labs Inc.
Class IINature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 114 mcg], 3 Grain (195 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3312-4; b) 60-count bottles, NDC 64727-3312-5; c) 90-count bottles, NDC 64727-3312-6; d) 100-count bottles, NDC 64727-3312-1; and e) 1,000-count bottles, NDC 64727-3312-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.2020-09-23
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Recalling firm: RLC Labs Inc.
Class INP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-330-01.2020-06-10
Superpotent Drug.
Recalling firm: Acella Pharmaceuticals, LLC
Class IILevoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New York, NY 10017, NDC 60793-855-012018-12-26
Superpotent Drug.
Recalling firm: Pfizer Inc.
Class IIThyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 0395-8077-62 Packaged by: Humco Texarkana, TX 75501 USA2018-10-24
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Recalling firm: Humco Holding Group, Inc
Class IIThyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-6580-43 Packaged by: Humco Texarkana, TX 75501 USA2018-10-24
CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Recalling firm: Humco Holding Group, Inc
Class ILevothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04.2018-08-29
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufactur
Recalling firm: Westminster Pharmaceuticals LLC
Class ILevothyroxine and Liothyronine (Thyroid Tablets, USP), 2 grain (120 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-158-04.2018-08-29
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufactur
Recalling firm: Westminster Pharmaceuticals LLC
Class ILevothyroxine and Liothyronine (Thyroid Tablets, USP), 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-157-04.2018-08-29
Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufactur
Recalling firm: Westminster Pharmaceuticals LLC
Class IILevothyroxine Sodium USP for prescription compounding, packaged in a) 1g (NDC 58597-8638-1); b) 5 g (NDC 58597-8638-2), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 483272018-02-28
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Recalling firm: American Pharmaceutical Ingredients LLC
Class IILevothyroxine Sodium 135 mcg/Liothyronine 15 mcg SR capsules, 90 count bottles, Rx only, Moore's Pharmacy Compounding, Corpus Christi, TX2017-03-01
Superpotent Drug and Subpotent Drug; potency failures obtained
Recalling firm: MOORE'S COMPOUNDING PHARMACY
Class IIAll T4-levothyroxine Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.2016-07-13
Lack of Processing Controls
Recalling firm: Reliable Rexall-A Compounding Pharmacy