Lupin Pharmaceuticals Inc. recalls Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles,…
- Recall date
- January 28, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0429-2019
- FDA classification
- Class III
- Brand / firm
- Lupin Pharmaceuticals Inc.
- Sold / distributed
- Nationwide within the United States.
Why it was recalled
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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