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Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC ...

FDA Recall #D-0429-2019 — Class III — January 28, 2019

Recall #D-0429-2019 Date: January 28, 2019 Classification: Class III Status: Terminated

Product Description

Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.

Reason for Recall

Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

9,930 bottles

Distribution

Nationwide within the United States.

Code Information

a) H804506 Exp. 06/2020; 803555 Exp. 04/2020; H805394, Exp. 08/2020 b) H804112 Exp. 05/2020; H803220 Exp. 03/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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