Recalls / Class II
Class IID-1015-2020
Product
Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47
- Affected lot / code info
- Lots: 8CE1644, 8CE1645, 8DE1401, 8DE1402, 8DE1403, 8DE1769, 8DE1773, 8EE1561, 8EE1562, 8FE1453, 8FE1454, 8GE1342, 8HE1224, 8KE2248, 8KE2833, 8JE1918, 8KE2247, 8ME2727, 8ME2729, 9DE2750, 9AE2836, 9AE2837, 9CE3403, 9CE3404, 9DE2749, 9EE2638, 9FE2977, 9GE2796, 9GE3229
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-1015-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.