Ascend Recalls Metformin Hydrochloride Tablets Due to Foreign Amlodipine Contamination
Ascend Laboratories LLC is recalling 1,739 bottles of Metformin Hydrochloride 500 mg tablets because Amlodipine tablets were found in the packaging.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall, and the presence of a different medication (Amlodipine) in a Metformin bottle poses a significant risk of incorrect dosing or adverse drug interactions, fitting the 'Severe' criteria for significant injury risk.
Plain-English summary
Ascend Laboratories LLC is recalling 1,739 bottles of Metformin Hydrochloride Tablets, USP 500 mg, 1000 count. The recall was initiated after a report that Amlodipine tablets were found inside bottles of Metformin Hydrochloride tablets. The affected product is identified by Lot 6121056 and has an expiration date of 5/2019.
The product was distributed in Alabama, Florida, Georgia, South Carolina, and Tennessee. It was manufactured by Alkem Laboratories Ltd. in Mumbai, India, and distributed by Ascend Laboratories, LLC in Montvale, New Jersey. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and contact their pharmacist or healthcare provider for guidance. The recall is limited to the specific lot and expiration date listed above.
The recalled product
- Product
- METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
- Brand
- METFORMIN HYDROCHLORIDE
- Manufacturer
- Ascend Laboratories LLC
- Category
- Drug — Prescription Medication
- Affected units
- 1,739
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 (2)
- Lot 6121056
- exp 5/2019
UPCs (4)
- 0367877221014
- 0367877218014
- 0367877414904
- 0367877413907
Distribution
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