December 2019 FDA Recall Drug by Lupin Pharmaceuticals Inc.
D-0635-2020 - Failed Impurities/Degradation Specifications

This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on December 13, 2019 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0635-2020

Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Initiated
12-13-2019
Reported
01-08-2020
Quantity
2,130 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84495
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 in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-19-2020
Product Description About Product Description
Full technical description of the product.
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.

Batch or Lot Expiration Information

Lot# H801686, Exp. 12/31/2019.