Class II
Terminated
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10
- Company
- Akorn, Inc.
- Recall Initiated
- March 12, 2019
- Posted
- March 27, 2019
- Recall Number
- D-1011-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 15,322 10 ml bottles
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Distribution
Nationwide USA and Puerto Rico
Lot / Code Info
Lot: 357647, EXP 04/2019
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