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
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
CGMP Deviations