Ofloxacin Ophthalmic Solution (PACK) – Defective Container (2013)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
PACK Pharmaceuticals, LLC
Lot Codes / Batch Numbers
Lot #:OW3061, OW3062. Exp. 05/15.
Products Sold
Lot #:OW3061,OW3062. Exp. 05/15.
PACK Pharmaceuticals, LLC is recalling Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The products are packaged in Lo due to Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients al. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026