Why it was recalled
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: P2000467, Exp 7/2022
Where it was sold
TX, CA, GA, PA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0290-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 20, 2021
- FDA report date
- Mar 10, 2021
- Quantity
- 1296 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-0290-2021, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 87193
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: P2000467, Exp 7/2022
- Postal code
- 08520-1401
- Report date
- Mar 10, 2021
- Product type
- Drugs
- Recall number
- D-0290-2021
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 1296 bottles
- Termination date
- Oct 12, 2023
- Reason for recall
- Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- TX, CA, GA, PA
- Recall initiation date
- Jan 20, 2021
- Initial firm notification
- Letter
- Center classification date
- Feb 26, 2021