Recalls / Class II
Class IID-0290-2021
Product
Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99
- Brand name
- Famotidine
- Generic name
- Famotidine
- Active ingredient
- Famotidine
- Route
- Oral
- NDCs
- 65862-859, 65862-860
- FDA application
- ANDA206530
- Affected lot / code info
- Lot #: P2000467, Exp 7/2022
Why it was recalled
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 1296 bottles
- Distribution pattern
- TX, CA, GA, PA
Timeline
- Recall initiated
- 2021-01-20
- FDA classified
- 2021-02-26
- Posted by FDA
- 2021-03-10
- Terminated
- 2023-10-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0290-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.