1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recall: Particulate Matter
1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in…
Why was 1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl recalled?
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Service Code 2T8232 , Lot Number 160970019C , Exp. Date 5/7/2016 ; Service Code 2T8878 , Lot Number 160450193M , Exp. Date 5/6/2016 ; Service Code 2T8878 , Lot Number 160470227M , Exp. Date 5/8/2016 ; Service Code 2T8878 , Lot Number 160590187M , Exp. Date 5/19/2016 ; Service Code 2T8878 , Lot Number 160630026M , Exp. Date 5/23/2016 ; Service Code 2T8878 , Lot Number 160700162M , Exp. Date 5/31/2016 ; Service Code 2T8878 , Lot Number 160710004M , Exp. Date 5/31/2016 ; Service Code 2T8878 , Lot Number 160740228M , Exp. Date 6/4/2016 ; Service Code 2T8878 , Lot Number 160750111M , Exp. Date 6/4/2016 ; Service Code 2T8878 , Lot Number 160900226M , Exp. Date 6/20/2016 ; Service Code 2T8878 , Lot Number 161080176M , Exp. Date 7/8/2016 ;
- Product
- 1.5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2T8232, (NDC 61553-232-97)250 ml in…
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 384 Medical Cassettes
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)