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Recall Observatory FDA recall evidence

Drug product

Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 01450 90008 6, NDC # 53228-002-01, Equibal Labs, Inc

D-0591-2024

June 26, 2024

Class II

Product summary

Firm
Equibal Inc
Event
Event 94843
Status
Terminated
Classification
Class II
Quantity
90/1 oz. tubes and 248/4 oz. bottles
Official record key
drug-enforcement:D-0591-2024

Official wording

Reason: CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.

Code information: Lot # a) BF063221, exp. date 03/04/2025, BF097221, exp. date 04/07/2025, b) BF097221 exp date 04/07/2025

Distribution pattern: Nationwide in the USA via internet sales.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations