Why it was recalled
GMP Deviations
Product description
Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
Lot numbers, UPCs & expiration codes
Lot #: KU455-4, Exp.10/30/2020
Where it was sold
Within the United States and Puerto Rico
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-0813-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 4, 2018
- FDA report date
- May 23, 2018
- Quantity
- 4,815 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Milbar Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0813-2018, exactly as published.
Show all FDA fields
- City
- East Haven
- State
- CT
- Status
- Terminated
- Country
- United States
- Event ID
- 80042
- Address
- 20 Commerce St
- Code information
- Lot #: KU455-4, Exp.10/30/2020
- Postal code
- 06512-4145
- Report date
- May 23, 2018
- Product type
- Drugs
- Recall number
- D-0813-2018
- Classification
- Class II
- Recalling firm
- Milbar Laboratories, Inc.
- Product quantity
- 4,815 tubes
- Termination date
- Jun 26, 2019
- Reason for recall
- GMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
- Distribution pattern
- Within the United States and Puerto Rico
- Recall initiation date
- May 4, 2018
- Initial firm notification
- Letter
- Center classification date
- May 15, 2018