10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl recall: Particulate Matter
10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only, Compounded by…
Why was 10 mcg/mL HYDROmorphone HCl and 0.0625% 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?
Lot Number 160470116M , Exp. Date 5/17/2016 ; Lot Number 160490123M , Exp. Date 5/19/2016 ; Lot Number 160800048M , Exp. Date 6/18/2016 ; Lot Number 160890060M , Exp. Date 6/27/2016 ; Lot Number 160940050M , Exp. Date 7/2/2016 ;
- Product
- 10 mcg/mL HYDROmorphone HCl and 0.0625% Bupivacaine HCl in 0.9% Sodium Chloride, 250 mL in 250 mL Baxter Intravia Bag, Rx Only, Compounded by…
- Recalling firm
- Pharmedium Services, LLC
- Quantity
- 55 bags
- Distribution
- Nationwide
- Recall date
- July 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)