Drug product
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
D-0295-2016
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 72351
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13,896 bottles
- Official record key
drug-enforcement:D-0295-2016
Official wording
Reason: 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.
Code information: Lot # 346191, Exp. 12/2016
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
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.