Akorn Recalls Latanoprost Ophthalmic Solution Due to Sterility Assurance Issues
Akorn, Inc. is recalling Latanoprost Ophthalmic Solution, 0.005%, because bottles were found empty, under-filled, or leaking, compromising sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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. The hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of serious injury or adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Akorn, Inc. is recalling 107,940 bottles of Latanoprost Ophthalmic Solution, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottles. The product is prescription-only and was distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The product was found to be empty, under-filled, or leaking. Specific lots affected include LAB15G52, LAB11G52, LAB18I52, LAB9L52, LAB1A62, and LAB9A62, with expiration dates ranging from 6/17 to 12/17.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-625-12
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Ophthalmic Solution
- Affected units
- 107,940
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 (10)
- Lot # LAB15G52
- LAB11G52
- Exp 6/17
- LAB18I52
- Exp 8/17
- LAB9L52
- 11/17
- LAB1A62
- LAB9A62
- Exp 12/17
Distribution
Distributed nationwide across the United States.
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