Recalls / Class II
Class IID-1020-2020
Product
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
- Affected lot / code info
- Lots: 9BE3161, 9CE3880, 9EE2500, 9FE2823, 9GE2656, 9HE3554, 9JE2676
Why it was recalled
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm
- Firm
- Perrigo Company PLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 515 Eastern Ave, Allegan, Michigan 49010-9070
Distribution
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2019-10-23
- FDA classified
- 2020-03-13
- Posted by FDA
- 2020-03-25
- Terminated
- 2020-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1020-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.