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PACK Pharmaceuticals, LLC Recall: Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 1657

PACK Pharmaceuticals, LLC Recall: Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 1657 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: PACK Pharmaceuticals, LLC; Product: Ofloxacin Ophthalmic Solution, USP 0.3%, 10mL, (NDC 16571-130-11). The products are packaged in Low Density Pol

Recalling firmPACK Pharmaceuticals, LLC
ProductOfloxacin 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.
Reason for recallDefective 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.
ClassificationClass III (least serious — unlikely to cause adverse health consequences)
StatusTerminated
DistributionNationwide and Puerto Rico.
Recall initiated20130909
Recall numberD-1069-2014
Categorydrug
StateIL
CountryUnited States

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