July 2019 FDA Recall Nystatin And Triamcinolone Acetonide by Lupin Pharmaceuticals Inc.
D-1518-2019 - Failed Content Uniformity Specifications

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on July 17, 2019 for the product Nystatin And Triamcinolone Acetonide. The FDA reported the reason for recall as failed content uniformity specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1518-2019

Reason for Recall
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Initiated
07-17-2019
Reported
07-31-2019
Quantity
33,939 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83350
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 within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-14-2020
Product Description About Product Description
Full technical description of the product.
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01

Batch or Lot Expiration Information

Lot# : K800245, Exp. Dec 2019; K900036 Exp. Sep 20; K900153, Exp. 09/2020

Affected Packages Involved in this Recall

68180-545-02 Nystatin And Triamcinolone Acetonide
68180-545-03 Nystatin And Triamcinolone Acetonide
68180-545-01 Nystatin And Triamcinolone Acetonide