American Health Packaging Recalls Ranitidine Tablets Due to NDMA Levels
American Health Packaging is recalling 53,619 cartons of Ranitidine Tablets, 150 mg, due to potential N-Nitrosodimethylamine (NDMA) amounts above FDA-established levels.
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 for significant injury or health risk scenarios.
Plain-English summary
American Health Packaging is recalling 53,619 cartons of Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only. The product is packaged and distributed by American Health Packaging in Columbus, Ohio. The affected NDC carton number is 60687-322-01 and the NDC Unit Dose Card number is 60687-322-11.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. The affected lots include 179516, 179745, 180712, 180819, 181403, 182544, 183155, 183236, 185739, 186600, and 186702, with expiration dates ranging from 12/31/2019 to 12/31/2020.
The product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.
The recalled product
- Product
- Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 53,619
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 (17)
- Lot
- expiry: Lots 179516
- 179745
- exp 12/31/2019
- Lot 180712
- exp 02/29/2020
- Lot 180819
- exp 04/30/2020
- Lots 181403
- 182544
- 183155
- 183236
- exp 05/31/2020
- Lots 185739
- 186600
- 186702
- exp 12/31/2020
Distribution
Distributed nationwide across the United States.
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