Blu Pharmaceuticals Recalls Metformin Tablets Due to Missing Inner Seals
Blu Pharmaceuticals is recalling Metformin Hydrochloride 1000 mg tablets because bottles were distributed without inner seals. The affected lot was distributed in New Jersey, Utah, Illinois, and Connecticut.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a packaging defect (missing inner seal) which is a low-risk contamination or labeling/packaging issue without reported injuries, fitting the Moderate severity criteria.
Plain-English summary
Blu Pharmaceuticals Inc is voluntarily recalling 101,500 tablets of Metformin Hydrochloride USP 1000 mg, 500 tablets Rx Only. The product is identified by NDC 24658-0292-05, Lot # 13E0014F1P8V, and an expiration date of 04/15. The tablets were manufactured by Blu Caribe in Dorado, PR, and distributed by Blu Pharmaceuticals in Franklin, NY.
The recall was initiated because the product was distributed without inner seals on the bottles. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected product was distributed in New Jersey, Utah, Illinois, and Connecticut. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or distributor for disposal or credit.
The recalled product
- Product
- Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05
- Manufacturer
- Blu Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Affected units
- 101,500
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 # 13E0014F1P8V
- Exp. 04/15
Distribution
Part of a larger recall action
This product is one of 2 recalled by Blu Pharmaceuticals 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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