Perrigo Recalls Ranitidine Tablets Due to Potential 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 severity score under the rubric, particularly given the potential for contamination with a known impurity.
Plain-English summary
Perrigo Company PLC is recalling Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. The affected products are sold under the NDC Equate (49035-800-75) and NDC Up & Up (11673-950-75) brands. 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 recall covers specific lot numbers including 8EE1514, 8EE1515, 8FE1353, 8GE1732, 8GE1864, 8HE1652, 8HE1653, 8JE2235, 8KE2724, 8KE2725, 8LE2367, 8ME2643, 8ME2644, 9AE2766, 9AE2767, 9CE3273, 9CE3274, 9DE2629, 9DE2630, 9EE2516, 9EE2517, 9FE2915, 9FE2916, 9GE2694, and 9GE3144. The products were distributed nationwide in the United States.
Consumers should check their medication bottles for the affected NDC numbers and lot codes. If the product matches the recalled items, consumers should stop using it and contact their pharmacist or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75
- 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 (20)
- Lots:8EE1514
- 8EE1515
- 8FE1353
- 8GE1732
- 8GE1864
- 8HE1652
- 8HE1653
- 8JE2235
- 8KE2724
- 8KE2725
- 8LE2367
- 8ME2643
- 8ME2644
- 9AE2766
- 9AE2767
- 9CE3273
- 9CE3274
- 9DE2629
- 9DE2630
- 9EE2516
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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