Status
Terminated
Drug Enforcement D-852-2013
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.
Classification
Class II
Report Date
August 14, 2013
Termination Date
April 18, 2016
Product Information
- 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.
- Product quantity
- 50,982 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Apotex Inc
- Address
-
380 Elgin Mills Rd East, N/A
Canada - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-852-2013
- Event ID
- 65882
- Recall initiation date
- June 25, 2013
- Center classification date
- August 8, 2013
- Code info
- Lot #: JX1877, Exp 06/13
- More code info
- —