Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination
Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, due to a CGMP deviation and possible contamination with the impurity N-nitrosodimethylamine.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) under the rubric for potential contamination with a hazardous impurity.
Plain-English summary
Perrigo Company PLC is voluntarily recalling Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. The recall is being conducted due to a Current Good Manufacturing Practice (CGMP) deviation and the possibility of contamination with the impurity N-nitrosodimethylamine.
The affected product is distributed nationwide in the United States under multiple brand names, including Basic Care, Berkley Jensen, CVS Health, DG Health, Kirkland, Kroger, Meijer, Rite Aid, and Walgreens. Specific lot numbers are listed in the recall documentation.
Consumers who have purchased these specific lots of Ranitidine tablets should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC
- Manufacturer
- Perrigo Company PLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lots:8CE1446
- 8DE1740
- 8FE1238
- 8FE1794
- 8GE1964
- 8JE2159
- 8ME2546
- 8ME2547
- 9BE3011
- 9CE3854
- 9DE3158
- 9FE3340
- 9HE3445
- 9JE2663
- 8AE1779
- 8BE1414
- 8DE1199
- 8DE1200
- 8DE1532
- 8EE1321
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Perrigo Company PLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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