AAA Pharmaceutical Recalls Ranitidine Tablets Due to NDMA Impurity
AAA Pharmaceutical is recalling Ranitidine 150 mg tablets because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).
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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant impurities like NDMA.
Plain-English summary
AAA Pharmaceutical, Inc. is recalling 34,272 bottles of Ranitidine 150 mg tablets (24-count bottles, NDC 37808-196-01). The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the discovery of the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API).
The affected product was distributed to one consignee, who may have further distributed it to their retail stores. The recall covers specific lot numbers with expiration dates ranging from August 2020 to April 2021.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
- Manufacturer
- AAA Pharmaceutical, Inc.
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)
- P134458
- Sept 2020 P134943
- Aug 2020 P135840
- Aug
- 2020 P136622
- April 2021 P136871
- April 2021 P137347
- April 2021 P137424
- April 2021
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by AAA Pharmaceutical, Inc. 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 2 products in this recall →Related recalls
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