Why it was recalled
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Product description
Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155
Lot numbers, UPCs & expiration codes
Lot #: 172185F, Exp 6/19
Where it was sold
Product was distributed throughout the United States
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-0086-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 24, 2018
- FDA report date
- Oct 31, 2018
- Quantity
- 5,016 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-0086-2019, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81004
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot #: 172185F, Exp 6/19
- Postal code
- 08807-2867
- Report date
- Oct 31, 2018
- Product type
- Drugs
- Recall number
- D-0086-2019
- Classification
- Class II
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 5,016 tubes
- Termination date
- Mar 6, 2020
- Reason for recall
- CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155
- Distribution pattern
- Product was distributed throughout the United States
- Recall initiation date
- Aug 24, 2018
- Initial firm notification
- Letter
- Center classification date
- Oct 22, 2018