Recalls / Class II
Class IID-1003-2020
Product
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
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 53,619 cartons
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2019-11-20
- FDA classified
- 2020-03-12
- Posted by FDA
- 2020-03-18
- Terminated
- 2022-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1003-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.