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Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle...

FDA Recall #D-0635-2020 — Class III — December 13, 2019

Recall #D-0635-2020 Date: December 13, 2019 Classification: Class III Status: Terminated

Product Description

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.

Reason for Recall

Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.

Recalling Firm

Lupin Pharmaceuticals Inc. — Baltimore, MD

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

2,130 bottles

Distribution

Nationwide in the U.S.

Code Information

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

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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