Recalls / Class III
Class IIID-0429-2019
Product
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.
- Affected lot / code info
- a) H804506 Exp. 06/2020; 803555 Exp. 04/2020; H805394, Exp. 08/2020 b) H804112 Exp. 05/2020; H803220 Exp. 03/2020
Why it was recalled
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 9,930 bottles
- Distribution pattern
- Nationwide within the United States.
Timeline
- Recall initiated
- 2019-01-28
- FDA classified
- 2019-02-05
- Posted by FDA
- 2019-02-13
- Terminated
- 2020-06-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0429-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.