Recalls / Class II
Class IID-0631-2020
Product
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
- Affected lot / code info
- [Case of 40] Lots 183723, 184278, exp 10/31/2020; Lot 187652, exp 05/31/2021; [Case of 50] Lot 177874, exp 01/31/ 2020; Lot 178413, exp 02/29/ 2020; Lot 183449, exp 10/31/2020; Lot 184445, exp 12/31/ 2020; Lot 186563, exp 03/31/ 2021; Lot 187691, exp 05/31/2021
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 1,692 cases of 40 and 50 cups
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2019-11-01
- FDA classified
- 2019-12-29
- Posted by FDA
- 2020-01-08
- Terminated
- 2022-08-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0631-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.