Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination
Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets 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 rating under the rubric, particularly given the potential for significant health risks associated with N-nitrosodimethylamine contamination.
Plain-English summary
Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. The recall involves specific lots of the product, including NDC Basic Care 0113-7950-01 and NDC CVS Health 59779-950-01.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation and the possibility of contamination with the impurity N-nitrosodimethylamine. The affected lots are distributed nationwide in the United States.
Consumers who have purchased these specific lots of Ranitidine tablets should stop using them and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Ranitidine
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 (19)
- Lots: 8BE1032
- 8BE1486
- 8CE1638
- 8DE1361
- 8DE1612
- 8FE1354
- 8GE1737
- 8HE1654
- 8JE2237
- 8KE2726
- 8LE2369
- 8ME2645
- 9AE2777
- 9CE3315
- 9DE2720
- 9EE2578
- 9FE2956
- 9GE2698
- 9GE3202
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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