American Health Packaging Recalls Ranitidine Syrup Due to NDMA Impurity
American Health Packaging is recalling specific lots of Ranitidine Syrup because the presence of the NDMA impurity was detected in the product.
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 detection of the NDMA impurity.
Plain-English summary
American Health Packaging is recalling specific lots of Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup. The recall involves 1,692 cases of 40 and 50 cups, which were distributed nationwide in the United States. The affected product is prescription-only and is identified by specific NDC codes and lot numbers listed in the recall documentation.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of the NDMA impurity in the product. NDMA is a chemical impurity that has been associated with potential health risks in certain medications.
Patients and healthcare providers should stop using the affected lots of Ranitidine Syrup and contact their healthcare provider for guidance on alternative treatments. The recalling firm, American Health Packaging, is responsible for managing the recall and providing further information to affected parties.
The recalled product
- Product
- Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
- Manufacturer
- American Health Packaging
- Category
- Drug — Oral Solution
- 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)
- [Case of 40] Lots 183723
- 184278
- exp 10/31/2020
- Lot 187652
- exp 05/31/2021
- [Case of 50] Lot 177874
- exp 01/31/ 2020
- Lot 178413
- exp 02/29/ 2020
- Lot 183449
- Lot 184445
- exp 12/31/ 2020
- Lot 186563
- exp 03/31/ 2021
- Lot 187691
Distribution
Distributed nationwide across the United States.
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