Perrigo Recalls Ranitidine Tablets Due to Potential N-Nitrosodimethylamine Contamination
Perrigo Company PLC is recalling specific lots of 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant impurities like N-nitrosodimethylamine.
Plain-English summary
Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. The product is identified by the NDC 11673-950-58 and is sold under the Up & Up brand. The recall covers specific lots: 9BE3161, 9CE3880, 9EE2500, 9FE2823, 9GE2656, 9HE3554, and 9JE2676.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation and the possibility of contamination with the impurity N-nitrosodimethylamine. The agency has classified this recall as Class II. The distribution pattern is listed as Nationwide USA.
Consumers who have purchased these specific lots of the product should stop using them and follow instructions from the recalling firm or their healthcare provider regarding disposal or return.
The recalled product
- Product
- Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58
- 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 (7)
- Lots: 9BE3161
- 9CE3880
- 9EE2500
- 9FE2823
- 9GE2656
- 9HE3554
- 9JE2676
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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