Drug product
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
D-0512-2019
Product summary
- Event
- Event 82127
- Status
- Terminated
- Classification
- Class III
- Quantity
- 12252 bottles
- Official record key
drug-enforcement:D-0512-2019
Official wording
Reason: Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Code information: Lot #: 7DT0280, 7ET0565, Exp. 02/19
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out of specification