Recalls / Class III
Class IIID-0635-2020
Product
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.
- Affected lot / code info
- Lot# H801686, Exp. 12/31/2019.
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 2,130 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-12-13
- FDA classified
- 2020-01-02
- Posted by FDA
- 2020-01-08
- Terminated
- 2020-10-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0635-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.