PACK Pharmaceuticals Recalls Ofloxacin Ophthalmic Solution Due to Container Defects
PACK Pharmaceuticals is recalling 126 bottles of Ofloxacin Ophthalmic Solution 0.3% because stability samples showed white solid residue on the exterior of the bottles.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for cosmetic or packaging-only problems.
Plain-English summary
PACK Pharmaceuticals, LLC is voluntarily recalling 126 bottles of Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL (NDC 16571-130-11). The affected product is identified by Lot #OW3071 with an expiration date of 06/2015. The 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 was initiated because stability samples of the product were noted to have white solid product residue on the exterior of the bottles. This residue was identified as dried active ingredients along with the preservative. The agency has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
The affected product was distributed nationwide and in Puerto Rico. Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). 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
- 126
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 (1)
- Lot #:OW3071.Exp. 06/2015.
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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