Class II
Terminated
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.
- Company
- Akorn, Inc.
- Recall Initiated
- December 16, 2019
- Posted
- February 19, 2020
- Recall Number
- D-0839-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 16,078 bottles
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Distribution
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lot #: 364667, Exp 12/20/2019
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