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Class II · ModerateActive recall

Preferred Pharmaceuticals Inc.

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot Codes: C2520W,Exp.12/31/2021; E0620F, Exp. 12/31/2021; G2020M, Exp. 4/30/2022; G2720A, Exp. 4/30/2022
Where it was soldDistributed to two physician consignees located in FL.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forPreferred Pharmaceuticals, Inc.
NDC68788-6932-1
Show the full FDA record
Full product labelPreferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
Recalling firmPreferred Pharmaceuticals, Inc.
DistributionDistributed to two physician consignees located in FL.
Quantity147 bottles (14,700 extended release tablets)
Recall initiated2021-04-28
Report date2021-05-26
Recall completed—
Recall numberD-0385-2021
ClassificationClass II
FDA statusOngoing
Origin on fileAnaheim CA United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.