FDA recall D-1170-2022

Akorn, Inc. · Class II · drug

Product

Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02

Reason for recall

Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.

Distribution

Nationwide in the U.S.

Key facts

Status
Terminated
Initiation date
2022-06-10
Report date
2022-07-06
Termination date
2023-09-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1170-2022