Why it was recalled
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Product description
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
Nationwide
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-0319-2020
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Sep 24, 2019
- FDA report date
- Nov 20, 2019
- Quantity
- 215,387 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D-0319-2020, exactly as published.
Show all FDA fields
- City
- North York
- Status
- Completed
- Country
- Canada
- Event ID
- 83871
- Address
- 150 Signet Drive
- Code information
- All lots remaining within expiry.
- Report date
- Nov 20, 2019
- Product type
- Drugs
- Recall number
- D-0319-2020
- Classification
- Class II
- Recalling firm
- Apotex Inc.
- Product quantity
- 215,387 bottles
- Reason for recall
- GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 24, 2019
- Initial firm notification
- Press Release
- Center classification date
- Nov 12, 2019