PACK Pharmaceuticals Recalls Ofloxacin Ophthalmic Solution Due to Container Defects
PACK Pharmaceuticals is recalling 32,029 bottles of Ofloxacin Ophthalmic Solution because stability samples showed white solid residue on the exterior of the bottles.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a cosmetic defect (exterior residue) rather than a contamination or safety hazard.
Plain-English summary
PACK Pharmaceuticals, LLC is recalling 32,029 bottles of Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL (NDC 16571-130-50). The affected products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip and individually packaged into fiberboard cartons. The recall covers Lot numbers OW3061 and OW3062 with an expiration date of 05/15.
The recall was initiated because stability samples of the products were noted to have some white solid product residue on the exterior of the bottles. This residue was identified as dried active ingredients along with the preservative.
The products were distributed nationwide and in Puerto Rico. Consumers should check their medication for the specific lot numbers and expiration dates listed above. If the product matches the recall description, consumers should stop using it and contact their pharmacist or healthcare provider for instructions on disposal or replacement.
The recalled product
- Product
- Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
- Manufacturer
- PACK Pharmaceuticals, LLC
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 32,029
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 #:OW3061
- OW3062. Exp. 05/15.
Distribution
Part of a larger recall action
This product is one of 6 recalled by PACK Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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