Recalls / Class II
Class IID-1170-2022
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
- Affected lot / code info
- Lot #: 378440, Exp. 07/31/2023
Why it was recalled
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 2,736 Bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2022-06-10
- FDA classified
- 2022-06-29
- Posted by FDA
- 2022-07-06
- Terminated
- 2023-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1170-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.