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.
Reported: February 19, 2020 Initiated: December 16, 2019 #D-0839-2020
Product Description
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.
Reason for Recall
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Details
- Recalling Firm
- Akorn Inc
- Units Affected
- 16,078 bottles
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Akorn Inc. Units affected: 16,078 bottles.
Why was this product recalled? ▼
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 19, 2020. Severity: Moderate. Recall number: D-0839-2020.
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