Why it was recalled
CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
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
Lot numbers, UPCs & expiration codes
Lot # a) BF063221, exp. date 03/04/2025, BF097221, exp. date 04/07/2025, b) BF097221 exp date 04/07/2025
Where it was sold
Nationwide in the USA via internet sales.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0591-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 26, 2024
- FDA report date
- Jul 17, 2024
- Quantity
- 90/1 oz. tubes and 248/4 oz. bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Equibal Inc
Original FDA data
Every field from FDA enforcement report D-0591-2024, exactly as published.
Show all FDA fields
- City
- Unionville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 94843
- Address
- 63-65 Jersey Ave
- Code information
- Lot # a) BF063221, exp. date 03/04/2025, BF097221, exp. date 04/07/2025, b) BF097221 exp date 04/07/2025
- Postal code
- 10988
- Report date
- Jul 17, 2024
- Product type
- Drugs
- Recall number
- D-0591-2024
- Classification
- Class II
- Recalling firm
- Equibal Inc
- Product quantity
- 90/1 oz. tubes and 248/4 oz. bottles
- Termination date
- Apr 7, 2026
- Reason for recall
- CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA via internet sales.
- Recall initiation date
- Jun 26, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 9, 2024