Class III
Terminated
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10
- Company
- Akorn, Inc.
- Recall Initiated
- August 21, 2015
- Posted
- November 25, 2015
- Recall Number
- D-0295-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,896 bottles
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot # 346191, Exp. 12/2016
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