Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Product description
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
Lot numbers, UPCs & expiration codes
P134457, Sept 2020 P135156, Aug 2020 P135156, Aug 2020 P135243, Aug 2020 P135877, Sept 2020 P136145, Aug 2020 P136146, Sept 2020 P136623, April 2021 P136728, April, 2021 P136994, April, 2021 P137348, April, 2021 P137423, April, 2021 P137499, April, 2021
Where it was sold
Product was distributed to one consignee who may have distributed the product further to their retail stores.
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-0646-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 26, 2019
- FDA report date
- Jan 15, 2020
- Quantity
- 31,536 (130-count bottles)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AAA Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-0646-2020, exactly as published.
Show all FDA fields
- City
- Lumberton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84583
- Address
- 681 Main St
- Code information
- P134457, Sept 2020 P135156, Aug 2020 P135156, Aug 2020 P135243, Aug 2020 P135877, Sept 2020 P136145, Aug 2020 P136146, Sept 2020 P136623, April 2021 P136728, April, 2021 P136994, April, 2021 P137348, April, 2021 P137423, April, 2021 P137499, April, 2021
- Postal code
- 08048-5013
- Report date
- Jan 15, 2020
- Product type
- Drugs
- Recall number
- D-0646-2020
- Classification
- Class II
- Recalling firm
- AAA Pharmaceutical, Inc.
- Product quantity
- 31,536 (130-count bottles)
- Termination date
- Mar 10, 2021
- Reason for recall
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
- Distribution pattern
- Product was distributed to one consignee who may have distributed the product further to their retail stores.
- Recall initiation date
- Dec 26, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 6, 2020