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.
Reported: January 8, 2020 Initiated: December 13, 2019 #D-0635-2020
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 2,130 bottles
- Distribution
- Nationwide in the U.S.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 2,130 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 8, 2020. Severity: Low. Recall number: D-0635-2020.
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