Why it was recalled
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Product description
Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
Lot numbers, UPCs & expiration codes
Lot, expiry: Lots 179516, 179745, exp 12/31/2019; Lot 180712, exp 02/29/2020; Lot 180819, exp 04/30/2020; Lots 181403, 182544, 183155, 183236, exp 05/31/2020; Lots 185739, 186600, 186702, exp 12/31/2020
Where it was sold
Nationwide USA
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-1003-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 20, 2019
- FDA report date
- Mar 18, 2020
- Quantity
- 53,619 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1003-2020, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 85070
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot, expiry: Lots 179516, 179745, exp 12/31/2019; Lot 180712, exp 02/29/2020; Lot 180819, exp 04/30/2020; Lots 181403, 182544, 183155, 183236, exp 05/31/2020; Lots 185739, 186600, 186702, exp 12/31/2020
- Postal code
- 43217-1188
- Report date
- Mar 18, 2020
- Product type
- Drugs
- Recall number
- D-1003-2020
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 53,619 cartons
- Termination date
- Aug 4, 2022
- Reason for recall
- CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
- Distribution pattern
- Nationwide USA
- Recall initiation date
- Nov 20, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2020