Why it was recalled
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
Product description
Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
Lot numbers, UPCs & expiration codes
Lot, expiry: Lot 3216, exp 04/23 and 3218, exp 10/23
Where it was sold
Nationwide in the USA
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-0326-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 10, 2023
- FDA report date
- Feb 22, 2023
- Quantity
- 3186 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Consolidated Chemical, Inc
Original FDA data
Every field from FDA enforcement report D-0326-2023, exactly as published.
Show all FDA fields
- City
- Saint Louis
- State
- MO
- Status
- Ongoing
- Country
- United States
- Event ID
- 91521
- Address
- 3224 S Kingshighway Blvd
- Code information
- Lot, expiry: Lot 3216, exp 04/23 and 3218, exp 10/23
- Postal code
- 63139-1114
- Report date
- Feb 22, 2023
- Product type
- Drugs
- Recall number
- D-0326-2023
- Classification
- Class II
- Recalling firm
- Consolidated Chemical, Inc
- Product quantity
- 3186 bottles
- Reason for recall
- CGMP Deviations: initiated due to violations of CGMP manufacturing practices
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 10, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2023