Why it was recalled
cGMP Deviations
Product description
Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 70223-001-06
Lot numbers, UPCs & expiration codes
All product within expiry
Where it was sold
Nationwide.
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-0621-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 28, 2018
- FDA report date
- Apr 18, 2018
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Elroselabs Inc.
Original FDA data
Every field from FDA enforcement report D-0621-2018, exactly as published.
Show all FDA fields
- City
- Sanford
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 79606
- Address
- 3875 Saint Johns Pkwy
- Code information
- All product within expiry
- Postal code
- 32771-6371
- Report date
- Apr 18, 2018
- Product type
- Drugs
- Recall number
- D-0621-2018
- Classification
- Class II
- Recalling firm
- Elroselabs Inc.
- Product quantity
- Unknown
- Termination date
- Dec 15, 2020
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Conzerol zero molluscum contagiosum, Topical Cream, Net weight 0.78 (22g), Elrose Labs, Sanford Fl 32771 USA --- NDC 70223-001-06
- Distribution pattern
- Nationwide.
- Recall initiation date
- Mar 28, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 6, 2018