Apotex Recalls Latanoprost Ophthalmic Solution Due to Sterility Concerns
Apotex Inc. is recalling Latanoprost Ophthalmic Solution, 0.005%, because it failed a preservative effectiveness test, raising concerns about potential microbial growth.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of infection or injury.
Plain-English summary
Apotex Inc. is voluntarily recalling 50,982 bottles of Latanoprost Ophthalmic Solution, 0.005% (125 mcg/2.5 mL), 2.5 mL bottle, Rx only. The product is identified by Lot # JX1877 and has an expiration date of 06/13. The recall was initiated because the product failed the Preservative Effectiveness Test (PET) at expiry, which means the product may be susceptible to microbial growth before the stated expiration date.
The recalled product was distributed nationwide. It was manufactured by Apotex Inc. in Toronto, Ontario, Canada, and manufactured for Apotex Corp. in Weston, FL. The NDC is 60505-0565-1 and the UPC is 3 60505 05651 4.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments. The product should be returned to the pharmacy or point of purchase.
The recalled product
- 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.
- Manufacturer
- Apotex Inc
- Category
- Drug — Ophthalmic Solution
- Affected units
- 50,982
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: JX1877
- Exp 06/13
Distribution
Distributed nationwide across the United States.
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