Status
Completed
Drug Enforcement D-0591-2024
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Classification
Class II
Report Date
July 17, 2024
Termination Date
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Product Information
- Product description
- 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
- Product quantity
- 90/1 oz. tubes and 248/4 oz. bottles
- Reason for recall
- CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA via internet sales.
Location & Firm
- Recalling firm
- Equibal Inc
- Address
-
63-65 Jersey Ave, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0591-2024
- Event ID
- 94843
- Recall initiation date
- June 26, 2024
- Center classification date
- July 9, 2024
- Code info
- Lot # a) BF063221, exp. date 03/04/2025, BF097221, exp. date 04/07/2025, b) BF097221 exp date 04/07/2025
- More code info
- —