Drug recall D-0097-2017
Product
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
Reason for recall
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Lots and codes
Lot #: 59310DD, Exp 1NOV2017
Recall details
- Recalling firm
- Hospira Inc., A Pfizer Company, Lake Forest, IL
- Quantity
- 4768 vials
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 16, 2016
- Terminated
- July 31, 2019
Related products
- Marcaine – drug information
- NDC 0409-2253 Marcaine · Bupivacaine Hydrochloride 225 mg/30mL · Hospira, Inc.
- NDC 0409-1587 Marcaine · Bupivacaine Hydrochloride 2.5 mg/mL · Hospira, Inc.
- NDC 0409-1752 Marcaine with Epinephrine · Bupivacaine Hydrochloride 2.5 mg/mL; Epinephrine Bitartrate… · Hospira, Inc.
- NDC 0409-1746 Marcaine with Epinephrine · Bupivacaine Hydrochloride 2.5 mg/mL; Epinephrine Bitartrate… · Hospira, Inc.
- NDC 0409-7535 Marcaine · Bupivacaine Hydrochloride 75 mg/30mL · Hospira, Inc.
- NDC 0409-0525 Marcaine · Bupivacaine Hydrochloride 250 mg/50mL · Hospira, Inc.
- NDC 0409-1582 Marcaine · Bupivacaine Hydrochloride 7.5 mg/mL · Hospira, Inc.
- NDC 0409-2510 Marcaine · Bupivacaine Hydrochloride 25 mg/10mL · Hospira, Inc.
- NDC 0409-1755 Marcaine with Epinephrine · Bupivacaine Hydrochloride 5 mg/mL; Epinephrine Bitartrate… · Hospira, Inc.
- NDC 0409-5010 Marcaine · Bupivacaine Hydrochloride 50 mg/10mL · Hospira, Inc.
- NDC 0409-1530 Marcaine · Bupivacaine Hydrochloride 150 mg/30mL · Hospira, Inc.
- NDC 0409-1749 Marcaine with Epinephrine · Bupivacaine Hydrochloride 5 mg/mL; Epinephrine Bitartrate… · Hospira, Inc.