Why it was recalled
Lack of Processing Controls (lack of assurance of conformity to specifications).
Product description
Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15 mL), b) 2 FL OZ (60 mL) bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
Lot numbers, UPCs & expiration codes
01-17-2020:45@4, 01-13-2020:40@27, BUD 7/7/2020 01-21-2020:43@11, BUD 7/18/2020 01-28-2020:88@15, 01-31-2020:73@6, BUD 7/26/2020 02-12-2020:43@16, 02-17-2020:86@5, BUD 8/10/2020 02-21-2020:23@1, BUD 8/16/2020
Where it was sold
Nationwide in the U.S.
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-1424-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 2, 2020
- FDA report date
- Aug 5, 2020
- Quantity
- 543 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MasterPharm LLC
Original FDA data
Every field from FDA enforcement report D-1424-2020, exactly as published.
Show all FDA fields
- City
- South Richmond Hill
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 85992
- Address
- 11502 Liberty Ave Fl 2
- Code information
- 01-17-2020:45@4, 01-13-2020:40@27, BUD 7/7/2020 01-21-2020:43@11, BUD 7/18/2020 01-28-2020:88@15, 01-31-2020:73@6, BUD 7/26/2020 02-12-2020:43@16, 02-17-2020:86@5, BUD 8/10/2020 02-21-2020:23@1, BUD 8/16/2020
- Postal code
- 11419-1902
- Report date
- Aug 5, 2020
- Product type
- Drugs
- Recall number
- D-1424-2020
- Classification
- Class II
- Recalling firm
- MasterPharm LLC
- Product quantity
- 543 units
- Termination date
- Feb 23, 2024
- Reason for recall
- Lack of Processing Controls (lack of assurance of conformity to specifications).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Formula 82M (Minoxidil 5%/Tretinoin 0.01%/Fluocinolone acetonide 0.01%), a) 0.5 FL OZ (15 mL), b) 2 FL OZ (60 mL) bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Jul 2, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 29, 2020