Recalls / Class II
Class IID-1021-2020
Product
Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; NDC Harris Teeter: 69256-041-71; NDC Kroger: 30142-600-71; NDC Major: 0904-6716-51; NDC Meijer: 41250-852-71; NDC Publix: 56062-099-71; NDC Rite Aid: 11822-0852-2; NDC Signature Care: 21130-116-71; NDC Topcare: 36800-852-71
- Affected lot / code info
- Lots: 8AE1744, 8BE1369, 8CE1377, 8CE1378, 8DE1103, 8DE1531, 8EE1700, 8FV0829, 8DE1722, 8EE1317, 8FE1635, 8GE1921, 8HE1342, 8KE2503R, 8JE2154, 8KE2503, 8LE2198, 8LE2597, 9AE2499, 9BE2862, 9BE2863, 9CE3723, 9DE2890, 9DE2891, 9EE2812, 9FE3187, 9GE2885, 9HE3435, 9JE2656
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-1021-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.