Perrigo Recalls Ranitidine Tablets Due to Possible N-Nitrosodimethylamine Contamination
Perrigo Company PLC is recalling specific lots of Regular Strength Acid Reducer 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 injury from N-nitrosodimethylamine contamination.
Plain-English summary
Perrigo Company PLC is recalling Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle (NDC 69842-293-06). 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. The specific lot numbers subject to this recall are 8FE1455, 8GE1343, 8HE1225, 8KE2834, 8KE2249, 8ME2730, 9AE2838, 9EE2639, and 9FE2993.
Consumers should check their medication bottles for the NDC number and lot numbers listed above. If the product matches the recalled items, consumers should stop using it and contact their pharmacist or healthcare provider for guidance on next steps.
The recalled product
- Product
- Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06
- 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 (9)
- Lots: 8FE1455
- 8GE1343
- 8HE1225
- 8KE2834
- 8KE2249
- 8ME2730
- 9AE2838
- 9EE2639
- 9FE2993
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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