Recalls / Class II
Class IID-1023-2020
Product
Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09
- Affected lot / code info
- Lots: 8AE1884, 8BE1466, 8DE1318, 8CE1617, 8DE1319, 8EE1326, 8DE1611, 8DE1767, 8FE1350, 8FE1352, 8GE1736, 8GE1840, 8GE1859, 8HE1592, 8HE1593, 8HE1594, 8JE2234, 9CE3263, 8JE2233, 8LE2360, 8KE2704, 8ME2641, 8ME2642, 9AE2675, 9AE2676, 9CE3265, 9CE3881, 9DE2585, 9EE2501, 9EE2502, 9FE2825, 9FE2827, 9GE2657, 9GE3124, 9GE3122, 9HE3555
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-1023-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.