January 2013 FDA Recall Drug by Lupin Pharmaceuticals Inc.
D-264-2013 - Discoloration; Product may not meet specifications for color description once reconstituted.

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on January 31, 2013 for the product Drug. The FDA reported the reason for recall as discoloration; product may not meet specifications for color description once reconstituted.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-264-2013

Reason for Recall
Discoloration; Product may not meet specifications for color description once reconstituted.
Initiated
01-31-2013
Reported
04-24-2013
Quantity
64,368 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64325
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Lupin 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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-11-2013
Product Description About Product Description
Full technical description of the product.
Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.

Batch or Lot Expiration Information

Lot# s: MSA 2021A, MSA 2024A, MSA 2025A, Exp July 2014