Why it was recalled
Lack of Processing Controls.
Product description
Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Lot numbers, UPCs & expiration codes
All lots remaining 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-1402-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 28, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 20 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Synthetopes Inc
Original FDA data
Every field from FDA enforcement report D-1402-2019, exactly as published.
Show all FDA fields
- City
- Conway
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 82969
- Address
- 216 Earnhardt St
- Code information
- All lots remaining within expiry.
- Postal code
- 29526-8287
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1402-2019
- Classification
- Class II
- Recalling firm
- Synthetopes Inc
- Product quantity
- 20 vials
- Termination date
- Oct 15, 2020
- Reason for recall
- Lack of Processing Controls.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
- Distribution pattern
- Nationwide.
- Recall initiation date
- May 28, 2019
- Initial firm notification
- Letter
- Center classification date
- Jun 20, 2019