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Class II: temporary or reversible health riskTerminated

Blu Pharmaceuticals Metformin Hydrochloride Tablets 500 mg Recall

Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Ca…

Blu Pharmaceuticals Inc · Franklin, KY

Risk level
Class II
Reported by FDA
May 14, 2014
Recall ID
D-1301-2014
Check your lot numberHow we source this data

Summary

Blu Pharmaceuticals recalled Metformin Hydrochloride Tablets 500 mg starting Mar 13, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1301-2014 on May 14, 2014. Reason: Defective container: Product distributed without inner seal on bottles. Status: Terminated.

Why it was recalled

Defective container: Product distributed without inner seal on bottles.

Product description

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

Lot numbers, UPCs & expiration codes

Lot # 13E0008F3P8V; Exp. 03/15

Where it was sold

NJ, UT, IL and CT

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1301-2014
Classification
Class II
Status
Terminated
Recall initiated
Mar 13, 2014
FDA report date
May 14, 2014
Quantity
14,000 tablets
Recall type
Voluntary: Firm initiated
Recalling firm
Blu Pharmaceuticals Inc

Original FDA data

Every field from FDA enforcement report D-1301-2014, exactly as published.

Show all FDA fields
City
Franklin
State
KY
Status
Terminated
Country
United States
Event ID
67739
Address
301 Robey St
Code information
Lot # 13E0008F3P8V; Exp. 03/15
Postal code
42134-1032
Report date
May 14, 2014
Product type
Drugs
Recall number
D-1301-2014
Classification
Class II
Recalling firm
Blu Pharmaceuticals Inc
Product quantity
14,000 tablets
Termination date
Jun 10, 2015
Reason for recall
Defective container: Product distributed without inner seal on bottles.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
NJ, UT, IL and CT
Recall initiation date
Mar 13, 2014
Initial firm notification
Letter
Center classification date
May 5, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1301-2014, published May 14, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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