Drug product
Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15
D-0679-2017
Product summary
- Event
- Event 76756
- Status
- Terminated
- Classification
- Class III
- Quantity
- N/A
- Official record key
drug-enforcement:D-0679-2017
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: Lot #: 244660F, Exp. FEB 2018
Distribution pattern: nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications