Why it was recalled
Incorrect labeling: Incorrect or missing lot and/or exp date
Product description
PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.
Lot numbers, UPCs & expiration codes
Lots: SU9079A, SU9079B, Exp 4/5/2020
Where it was sold
Nationwide in the U.S.
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-0154-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 21, 2019
- FDA report date
- Nov 6, 2019
- Quantity
- 19,390 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Original FDA data
Every field from FDA enforcement report D-0154-2020, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 84106
- Address
- 4500 12th Street Ext
- Code information
- Lots: SU9079A, SU9079B, Exp 4/5/2020
- Postal code
- 29172-3025
- Report date
- Nov 6, 2019
- Product type
- Drugs
- Recall number
- D-0154-2020
- Classification
- Class III
- Recalling firm
- Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
- Product quantity
- 19,390 syringes
- Termination date
- May 7, 2020
- Reason for recall
- Incorrect labeling: Incorrect or missing lot and/or exp date
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Oct 21, 2019
- Initial firm notification
- Letter
- Center classification date
- Oct 28, 2019