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Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manuf...

FDA Recall #D-1170-2022 — Class II — June 10, 2022

Recall #D-1170-2022 Date: June 10, 2022 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Akorn, Inc. — Lake Forest, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2,736 Bottles

Distribution

Nationwide in the U.S.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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