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Class II · ModerateRecall completed

Fulvestrant

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

Does this affect you?
Check your lot numberLot # B200076; Exp 31 JAN 2024
Where it was soldNationwide.
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

Failed Impurities/Degradation Specifications

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

Made byCadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534 foreign manufacturer
Brand nameFULVESTRANT
Generic nameFULVESTRANT
Active ingredient(s)FULVESTRANT
Distributed by / forZydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534
NDC70710-1688-8
Show the full FDA record
Full product labelFulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionNationwide.
Quantity1116 boxes
Recall initiated2022-07-15
Report date2022-08-24
Recall completed2024-06-18
Recall numberD-1351-2022
ClassificationClass II
FDA statusTerminated
Origin on filePennington NJ 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.