Home / Recalls / PACK Pharmaceuticals, LLC / D-1069-2014

D-1069-2014 Class III Terminated

Recalled by PACK Pharmaceuticals, LLC — Buffalo Grove, IL

Recall Details

Product Type
Drugs
Report Date
February 12, 2014
Initiation Date
September 9, 2013
Termination Date
April 11, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
126 bottles

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide and Puerto Rico.

Code Information

Lot #:OW3071.Exp. 06/2015.

Other recalls by PACK Pharmaceuticals, LLC

  • D-1068-2014 Class III — Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The product (September 9, 2013)
  • D-1070-2014 Class III — Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-50). (September 9, 2013)
  • D-1072-2014 Class III — Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). (September 9, 2013)
  • D-1073-2014 Class III — Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 10mL, (NDC 16571-141-10). (September 9, 2013)
  • D-1071-2014 Class III — Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10) (September 9, 2013)
  • D-1422-2012 Class III — Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufacture (March 9, 2012)