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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, 65 tablets per bottle. The recall involves multiple store brands, including Basic Care, CVS Health, Equate, Good Neighbor Pharmacy, Kroger, Topcare, Up & Up, and Walgreens.
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 products were distributed nationwide in the United States.
Consumers who have purchased these specific lot numbers should stop using the product and return it to the place of purchase for a refund or contact the manufacturer for further instructions.
The recalled product
- 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…
- 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: 8AE1884
- 8BE1466
- 8DE1318
- 8CE1617
- 8DE1319
- 8EE1326
- 8DE1611
- 8DE1767
- 8FE1350
- 8FE1352
- 8GE1736
- 8GE1840
- 8GE1859
- 8HE1592
- 8HE1593
- 8HE1594
- 8JE2234
- 9CE3263
- 8JE2233
- 8LE2360
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.
See all 17 products in this recall →Related recalls
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