Drug product
Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). 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.
D-1072-2014
Product summary
- Event
- Event 66595
- Status
- Terminated
- Classification
- Class III
- Quantity
- 122,551 bottles
- Official record key
drug-enforcement:D-1072-2014
Official wording
Reason: 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.
Code information: Lot #:NDW3065,NDW3066,NDW3067,NDW3068,NDW3069. Exp.05/15.
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Unknown
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.