Drug product
Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodium chloride 0.9%, Epidural Use Only, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 36141, NDC# 61553-197-50
D-1823-2015
Product summary
- Event
- Event 71844
- Status
- Terminated
- Classification
- Class I
- Quantity
- 20 bags
- Official record key
drug-enforcement:D-1823-2015
Official wording
Reason: Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).
Code information: Lot #: 143140080M, Exp 02/09/15; 143210133M, Exp 02/16/15; 143490031M, Exp 03/16/15
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter