Recalls / Class III
Class IIID-1069-2014
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.
- Affected lot / code info
- Lot #:OW3071.Exp. 06/2015.
Why it was recalled
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.
Recalling firm
- Firm
- PACK Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1110 W Lake Cook Rd, Ste 301, Buffalo Grove, Illinois 60089-1944
Distribution
- Quantity
- 126 bottles
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2013-09-09
- FDA classified
- 2014-02-04
- Posted by FDA
- 2014-02-12
- Terminated
- 2014-04-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1069-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.