FDAClass IIMay 14, 2014

Metformin Hydrochloride Tablets USP 1000 mg recall

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

Why was Metformin Hydrochloride Tablets USP 1000 mg recalled?

Defective container: Product distributed without inner seal on bottles.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 13E0014F1P8V; Exp. 04/15

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
Recalling firm
Blu Pharmaceuticals Inc
Quantity
101,500 tablets
Distribution
NJ, UT, IL and CT
Recall date
May 14, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls