D-0512-2019 Class III Terminated
FDA drug recall D-0512-2019 was initiated by Perrigo New York, Inc. on February 13, 2019 and is designated Class III. Reason for recall: Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing. The recall status is terminated (terminated September 8, 2021). Affected quantity: 12252 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 27, 2019
- Initiation Date
- February 13, 2019
- Termination Date
- September 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12252 bottles
Product Description
Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09
Reason for Recall
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 7DT0280, 7ET0565, Exp. 02/19