D-1071-2014 Class III Terminated
FDA drug recall D-1071-2014 was initiated by PACK Pharmaceuticals, LLC on September 9, 2013 and is designated Class III. 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 … The recall status is terminated (terminated April 11, 2014). Affected quantity: 78 bottles.
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
- 78 bottles
Product Description
Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). 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 #:NW3071. Exp. 06/15.