Latanoprost Ophthalmic Solution — Class II drug recall D-852-2013
Terminated recall by Apotex Inc, reported 2013-08-14, distributed nationwide. Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the prod
| Recall number | D-852-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc, Richmond Hill, N/A, Canada |
| Recall initiated | 2013-06-25 |
| Classified | 2013-08-08 |
| Reported by FDA | 2013-08-14 |
| Terminated | 2016-04-18 |
| Distributed | Nationwide (US) |
| Quantity | 50,982 bottles |
| Reason classes | microbial contamination, sterility |
| UPC / GTIN / UDI-DI | 00360505056514 |
| NDC | 60505-0565-01 |
| Lot numbers | 06/13, JX1877 |
Product
Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario Canada M9L 1T9; Manufactured for: Apotex Corp., Weston, FL 33326; NDC 60505-0565-1; UPC 3 60505 05651 4.
Reason for recall
Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-852-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.