AAA Pharmaceutical Recalls Ranitidine Tablets Due to NDMA Impurity
AAA Pharmaceutical is recalling specific lots of 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the presence of a known carcinogenic impurity (NDMA) in the medication.
Plain-English summary
AAA Pharmaceutical, Inc. is recalling 31,536 bottles of Ranitidine 150 mg tablets (130 count, NDC 37808-196-04). The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection 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 the product to their retail stores. The recall covers specific lots with expiration dates ranging from August 2020 to April 2021, including lot numbers P134457, P135156, P135243, P135877, P136145, P136146, P136623, P136728, P136994, P137348, P137423, and P137499.
Consumers should check their medication for the NDC 37808-196-04 and the specific lot numbers listed above. If the product matches the recalled description, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatments.
The recalled product
- Product
- Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
- Manufacturer
- AAA Pharmaceutical, Inc.
- Category
- Drug — Prescription Medication
- Hazard
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 (15)
- P134457
- Sept 2020 P135156
- Aug 2020 P135156
- Aug 2020 P135243
- Aug 2020 P135877
- Sept 2020 P136145
- Aug 2020 P136146
- Sept 2020 P136623
- April 2021 P136728
- April
- 2021 P136994
- 2021 P137348
- 2021 P137423
- 2021 P137499
- 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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