Drug product

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

D-1011-2019

March 12, 2019

Class II

Product summary

Firm: Akorn Inc
Event: Event 82375
Status: Terminated
Classification: Class II
Quantity: 15,322 10 ml bottles
Official record key: drug-enforcement:D-1011-2019

Official wording

Reason: Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.

Code information: Lot: 357647, EXP 04/2019

Distribution pattern: Nationwide USA and Puerto Rico

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.