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.

FDA recall notice · announced February 13, 2019 · Lupin Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.

Notes

Distribution: Nationwide within the United States.
Lot/code information: a) H804506 Exp. 06/2020; 803555 Exp. 04/2020; H805394, Exp. 08/2020 b) H804112 Exp. 05/2020; H803220 Exp. 03/2020
Quantity: 9,930 bottles
Status: Terminated
Products in this recall event:
- 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. (D-0429-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.