Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product description
Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
Lot numbers, UPCs & expiration codes
Batch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021
Where it was sold
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
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-0648-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 7, 2020
- FDA report date
- Jan 15, 2020
- Quantity
- 1,632 bottes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Appco Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0648-2020, exactly as published.
Show all FDA fields
- City
- Piscataway
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84610
- Address
- 262 Old New Brunswick Rd Unit N
- Code information
- Batch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021
- Postal code
- 08854-3756
- Report date
- Jan 15, 2020
- Product type
- Drugs
- Recall number
- D-0648-2020
- Classification
- Class II
- Recalling firm
- Appco Pharma LLC
- Product quantity
- 1,632 bottes
- Termination date
- Apr 24, 2020
- Reason for recall
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
- Distribution pattern
- Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
- Recall initiation date
- Jan 7, 2020
- Initial firm notification
- Press Release
- Center classification date
- Jan 7, 2020