FDA Drug recall D-0429-2019
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, Manufactur…
- FDA Drug
- Class III
- terminated
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class III recall of 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, Manufactur… by Lupin Pharmaceuticals, citing failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0429-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-01-28 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Identifiers
| code_info | a) H804506 Exp. 06/2020; 803555 Exp. 04/2020; H805394, Exp. 08/2020 b) H804112 Exp. 05/2020; H803220 Exp. 03/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0429-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.