September 2018 FDA Recall Drug by Dr. Reddy's Laboratories, Inc.
D-0007-2019 - Failed stability specifications - An out of specification result was observed for the test parameter

This Class II drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on September 21, 2018 for the product Drug. The FDA reported the reason for recall as failed stability specifications - an out of specification result was observed for the test parameter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0007-2019

Reason for Recall
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Initiated
09-21-2018
Reported
10-10-2018
Quantity
35020 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81083
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.
Dr. Reddy's Laboratories, 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.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-17-2023
Product Description About Product Description
Full technical description of the product.
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India

Batch or Lot Expiration Information

Lot# : a) D06017, D06018, Exp 9/18; D06028 Exp 10/18; b) D06014, D06015, D06016, Exp 9/18; D06024, D06025, D06026, D06027, Exp 10/2018; c) D06011, D06012, D06013, Exp 9/18; D06020, D06021, D06022, D06023, Exp 10/2018