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
Reported: March 27, 2019 Initiated: March 12, 2019 #D-1011-2019
Product Description
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
Reason for Recall
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Details
- Recalling Firm
- Akorn Inc
- Units Affected
- 15,322 10 ml bottles
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn Inc. Units affected: 15,322 10 ml bottles.
Why was this product recalled? ▼
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 27, 2019. Severity: Moderate. Recall number: D-1011-2019.
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