Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
FDA recall notice · announced March 28, 2018 · Akorn
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
The product
Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60.
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Notes
Distribution: Nationwide in the USA and Puerto Rico
Lot/code information: Lot# 2062900, Exp 05/18
Quantity: 4,128 bottles
Status: Terminated
Products in this recall event:
- Triamcinolone Acetonide Lotion, USP 0.1%, 60 mL bottle, Rx Only, Marketed by: VersaPharm Incorporated, Marietta, GA 30062; Manufactured by: Ei LLC, Kannapolis, NC 28083, NDC 61748-220-60. (D-0617-2018)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.