RecallRadar

FDA Drug recall D-1161-2014

Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only…

On 2014-03-26 the FDA classified a Class I recall of Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only… by Hospira, citing presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1161-2014
ClassificationClass I
Statusterminated
Initiated2013-10-18
Published2014-03-26
Last updated2026-09-13 11:51 UTC
CompanyHospira
DistributionUS

Product

Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.

Reason

Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.

Identifiers

ndc0409-1559-18
ndc0409-1559-10
ndc0409-1559-19
ndc0409-1559-30
ndc0409-1560-18
ndc0409-1560-10
ndc0409-1560-19
ndc0409-1560-29
ndc0409-1582-18
ndc0409-1582-10
ndc0409-1582-19
ndc0409-1582-29
ndc0409-1587-50
ndc0409-1610-50
ndc0409-1746-70
ndc0409-1746-10
ndc0409-1746-71
ndc0409-1746-30
ndc0409-1749-70
ndc0409-1749-10
ndc0409-1749-71
ndc0409-1749-29
ndc0409-1752-50
ndc0409-1755-50
ndc0409-2510-01
ndc0409-2510-25
ndc0409-7535-01
ndc0409-7535-25
ndc0409-1250-01
ndc0409-1250-25
ndc0409-5010-01
ndc0409-5010-25
ndc0409-1530-01
ndc0409-1530-25
ndc0409-0525-01
ndc0409-0525-25
ndc0409-7510-01
ndc0409-7510-25
ndc0409-2253-01
ndc0409-2253-25
code_infoLot 25-220-DD, Exp 1JAN2015

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1161-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.