Drug product
Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15
D-0678-2017
Product summary
- Event
- Event 76756
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0678-2017
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: Lot #: 244661F, Exp. Feb 2018
Distribution pattern: nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications