Multi-event March 2014 FDA Recall Drug by Blu Pharmaceuticals Inc

This Multi-event Class II drug recall was voluntarily initiated by Blu Pharmaceuticals Inc on March 13, 2014 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed in NJ, UT, IL and CT and the recall is currently terminated.

Reported Recall Events

D-1301-2014 TERMINATED D-1302-2014 TERMINATED

Recall Number: D-1301-2014

Reason for Recall
Defective container: Product distributed without inner seal on bottles.
Initiated
03-13-2014
Reported
05-14-2014
Quantity
14,000 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67739
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Blu Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NJ, UT, IL and CT
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-10-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 13E0008F3P8V; Exp. 03/15

Recall Number: D-1302-2014

Reason for Recall
Defective container: Product distributed without inner seal on bottles.
Initiated
03-13-2014
Reported
05-14-2014
Quantity
101,500 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67739
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Blu Pharmaceuticals Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
NJ, UT, IL and CT
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-10-2015
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 13E0014F1P8V; Exp. 04/15