Why it was recalled
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Product description
REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670
Lot numbers, UPCs & expiration codes
Lot/Batch #: BL 2844, Expiration date 2/19/2023
Where it was sold
Nationwide in 17 States to 45 doctors.
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-0668-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 25, 2022
- FDA report date
- Mar 30, 2022
- Quantity
- 1119 (1 oz.) bottles/ 772 (3 oz.) tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Blaine Labs Inc
Original FDA data
Every field from FDA enforcement report D-0668-2022, exactly as published.
Show all FDA fields
- City
- Santa Fe Springs
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 89481
- Address
- 11037 Lockport Pl
- Code information
- Lot/Batch #: BL 2844, Expiration date 2/19/2023
- Postal code
- 90670-4634
- Report date
- Mar 30, 2022
- Product type
- Drugs
- Recall number
- D-0668-2022
- Classification
- Class I
- Recalling firm
- Blaine Labs Inc
- Product quantity
- 1119 (1 oz.) bottles/ 772 (3 oz.) tubes
- Termination date
- Aug 1, 2022
- Reason for recall
- Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670
- Distribution pattern
- Nationwide in 17 States to 45 doctors.
- Recall initiation date
- Jan 25, 2022
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 18, 2022