Blu Pharmaceuticals Recalls Metformin Tablets Due to Missing Inner Seals
Blu Pharmaceuticals is recalling 14,000 Metformin Hydrochloride tablets because the bottles were distributed without inner seals. The affected product 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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard is a packaging defect (missing inner seal) rather than a direct chemical or biological contamination, and no illnesses or injuries are reported in the source text.
Plain-English summary
Blu Pharmaceuticals Inc is voluntarily recalling 14,000 tablets of Metformin Hydrochloride Tablets USP 500 mg. The recall is due to a defective container issue where the product was distributed without the inner seal on the bottles. The specific lot number is 13E0008F3P8V with an expiration date of 03/15.
The affected product was distributed in New Jersey, Utah, Illinois, and Connecticut. The tablets are prescription-only and were manufactured by Blu Caribe in Dorado, Puerto Rico, and distributed by Blu Pharmaceuticals in Franklin, New York.
Consumers who have this specific lot of Metformin Hydrochloride tablets should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall is limited to the specific lot and expiration date listed above.
The recalled product
- Product
- Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05
- Manufacturer
- Blu Pharmaceuticals Inc
- Category
- Drug — Prescription Medication
- Affected units
- 14,000
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 # 13E0008F3P8V
- Exp. 03/15
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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