Lupin Pharmaceuticals Inc. recalls Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lup…
- Recall date
- December 13, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0635-2020
- FDA classification
- Class III
- Brand / firm
- Lupin Pharmaceuticals Inc.
- Sold / distributed
- Nationwide in the U.S.
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Class III means the product violates regulations but is not likely to cause harm.
What 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.
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