Home / Recalls / Akorn Inc / D-0839-2020

D-0839-2020 Class II Terminated

Recalled by Akorn Inc — Lake Forest, IL

FDA drug recall D-0839-2020 was initiated by Akorn Inc on December 16, 2019 and is designated Class II. Reason for recall: Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product. The recall status is terminated (terminated July 29, 2022). Affected quantity: 16,078 bottles.

Recall Details

Product Type
Drugs
Report Date
February 19, 2020
Initiation Date
December 16, 2019
Termination Date
July 29, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,078 bottles

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.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lot #: 364667, Exp 12/20/2019

Other recalls by Akorn Inc

  • D-0819-2023 Class II — Levofloxacin Oral Solution, 25 mg/mL, packaged in a) 100 mL bottles, b) 200 mL b (April 26, 2023)
  • D-0790-2023 Class II — Calcitriol Injection 1 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Opera (April 26, 2023)
  • D-0801-2023 Class II — DOCU LIQUID (docusate sodium, 50 mg/5 mL), packaged in 473mL bottles and b)10mL (April 26, 2023)
  • D-0858-2023 Class II — Calcitriol Injection 2 mcg/mL, 1 mL ampules Rx Only, Distributed by: Akorn Opera (April 26, 2023)
  • D-0824-2023 Class II — Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx (April 26, 2023)
  • D-0842-2023 Class II — Ropivacaine Hydrochloride Injection USP, 0.5%, 150mg/30 mL (5 mg/mL), 30 mL Sing (April 26, 2023)
  • D-0783-2023 Class II — Albuterol Sulfate Syrup, 2mg (base), 16 fl oz (473 mL) per bottle, Rx only, Dist (April 26, 2023)
  • D-0802-2023 Class II — Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intrav (April 26, 2023)
  • D-0792-2023 Class II — Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles, Rx Only, Distribu (April 26, 2023)
  • D-0826-2023 Class II — Lorazepam Oral Concentrate, USP, 2mg per mL, 30 mL bottles, Rx Only, Sterile, Di (April 26, 2023)

FDA data resources