0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number 160960175M; Exp. Date 5/6/2016 Lot Number 160970036M; Exp. Date 5/7/2016 Lot Number 161080071M; Exp. Date 5/18/2016
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Pharmedium Services, LLC
- Reason for Recall:
- Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
0.5 mcg/mL Sufentanil Citrate and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassette, Service Code 2T8317, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-317-52
Product Codes/Lot Numbers:
Lot Number 160960175M; Exp. Date 5/6/2016 Lot Number 160970036M; Exp. Date 5/7/2016 Lot Number 161080071M; Exp. Date 5/18/2016
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1371-2016
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