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
Reported: May 13, 2015 Initiated: March 31, 2015 #D-0992-2015
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
Details
- Recalling Firm
- Cody Laboratories, Inc.
- Units Affected
- 19,139 bottles
- Distribution
- Nationwide
- Location
- Cody, WY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cody Laboratories, Inc.. Units affected: 19,139 bottles.
Why was this product recalled? ▼
Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 13, 2015. Severity: Moderate. Recall number: D-0992-2015.
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