Perrigo Recalls Ranitidine Tablets Due to Potential Impurity Contamination
Perrigo is recalling specific lots of Maximum Strength Acid Reducer 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 agency classification is FDA Class II, and the hazard involves potential contamination with N-nitrosodimethylamine, a known carcinogenic impurity, which aligns with the 'Severe' criteria for significant health risks.
Plain-English summary
Perrigo Company PLC is recalling specific lots of Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. The affected products are sold under the Equate and Up & Up brands with NDC codes 49035-608-75 and 11673-023-75, respectively. The recall is nationwide.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation and the possibility of contamination with the impurity N-nitrosodimethylamine. The source text does not specify the number of affected units, the exact distribution dates, or any reported illnesses or injuries.
Consumers with the affected lots should stop using the product and contact their healthcare provider or the recalling firm for further instructions. The specific lot numbers subject to this recall are listed in the official FDA notice.
The recalled product
- Product
- Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75
- 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: 8EE1702
- 8EE1703
- 8EE1704
- 8FE1724
- 8GE1942
- 8HE1396
- 8HE1397
- 8JE2156
- 8KE2521
- 8KE2523
- 8LE2255
- 8LE2665
- 8LE2668
- 9AE2541
- 9AE2542
- 9AE2543
- 9BE2993
- 9BE2994
- 9BE2995
- 9CE3735
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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