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Recall Observatory FDA recall evidence

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

D-1170-2022

June 10, 2022

Class II

Product summary

Firm
Akorn, Inc.
Event
Event 90442
Status
Terminated
Classification
Class II
Quantity
2,736 Bottles
Official record key
drug-enforcement:D-1170-2022

Official wording

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

Code information: Lot #: 378440, Exp. 07/31/2023

Distribution pattern: Nationwide in the U.S.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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