# FDA recall D-852-2013

> **Apotex Inc** · Class II · drug recall initiated 2013-06-25.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-852-2013
- **Recalling firm:** Apotex Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-25
- **Report date:** 2013-08-14
- **Termination date:** 2016-04-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond Hill, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-852-2013

## Citation

> AI Analytics. FDA recall D-852-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-852-2013. Source: US FDA. Licensed CC0.

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