D-0992-2015 Class II Terminated
FDA drug recall D-0992-2015 was initiated by Cody Laboratories, Inc. on March 31, 2015 and is designated Class II. Reason for recall: Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL The recall status is terminated (terminated October 14, 2015). Affected quantity: 19,139 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 13, 2015
- Initiation Date
- March 31, 2015
- Termination Date
- October 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,139 bottles
Product Description
C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 by Cody Laboratories, Inc. Cody, WY 82414
Reason for Recall
Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL
Distribution Pattern
Nationwide
Code Information
Lot 14834012, Exp 01/2016