D-852-2013 Class II Terminated
FDA drug recall D-852-2013 was initiated by Apotex Inc on Jun 25, 2013 and is designated Class II. 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. The recall status is terminated (terminated Apr 18, 2016). Affected quantity: 50,982 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 14, 2013
- Initiation Date
- Jun 25, 2013
- Termination Date
- Apr 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50,982 bottles
Product description
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 pattern
Nationwide
Code information
Lot #: JX1877, Exp 06/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-852-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026