Marcaine With Epinephrine Injection, Solution
FDA Recall NDC 0409-1749
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Marcaine With Epinephrine (NDC 0409-1749). A significant event, classified as Class II, was initiated on Sep 16, 2016 by Hospira, Inc.. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
September 2016 Class II Recall: Lack of Assurance of Sterility and Subpotent Drug
Recall Number
Class II Terminated
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.
Sep 16, 2016
Oct 19, 2016
4768 vials
Recall Profile & Regulatory Data
Event ID
75156
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc., A Pfizer Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jul 31, 2019
Product Description
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.
Batch or Lot Expiration Information
Lot# : 59310DD, Exp 1NOV2017
Affected Packages Involved in this Recall
0409-1559-18Product
0409-1559-10Product
0409-1559-19Product
0409-1559-30Product
0409-1560-18Product
0409-1560-10Product
0409-1560-19Product
0409-1560-29Product
0409-1582-18Product
0409-1582-10Product
0409-1582-19Product
0409-1582-29Product
0409-1587-50Product
0409-1610-50Product
0409-1746-70Product
0409-1746-10Product
0409-1746-71Product
0409-1746-30Product
0409-1749-70Product
0409-1749-10Product
0409-1749-71Product
0409-1749-29Product
0409-1752-50Product
0409-1755-50Product
0409-2510-01Product
0409-2510-25Product
0409-7535-01Product
0409-7535-25Product
0409-1250-01Product
0409-1250-25Product
0409-5010-01Product
0409-5010-25Product
0409-1530-01Product
0409-1530-25Product
0409-0525-01Product
0409-0525-25Product
0409-7510-01Product
0409-7510-25Product
0409-2253-01Product
0409-2253-25Product
September 2016 Class II Recall: Lack of Assurance of Sterility and Subpotent Drug
Recall Number
Class II Terminated
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.
Sep 16, 2016
Oct 19, 2016
15 vials
Recall Profile & Regulatory Data
Event ID
75156
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc., A Pfizer Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jul 31, 2019
Product Description
Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.
Batch or Lot Expiration Information
Lot# : 60295DD, Ep 1DEC2017
Affected Packages Involved in this Recall
0409-1559-18Product
0409-1559-10Product
0409-1559-19Product
0409-1559-30Product
0409-1560-18Product
0409-1560-10Product
0409-1560-19Product
0409-1560-29Product
0409-1582-18Product
0409-1582-10Product
0409-1582-19Product
0409-1582-29Product
0409-1587-50Product
0409-1610-50Product
0409-1746-70Product
0409-1746-10Product
0409-1746-71Product
0409-1746-30Product
0409-1749-70Product
0409-1749-10Product
0409-1749-71Product
0409-1749-29Product
0409-1752-50Product
0409-1755-50Product
0409-2510-01Product
0409-2510-25Product
0409-7535-01Product
0409-7535-25Product
0409-1250-01Product
0409-1250-25Product
0409-5010-01Product
0409-5010-25Product
0409-1530-01Product
0409-1530-25Product
0409-0525-01Product
0409-0525-25Product
0409-7510-01Product
0409-7510-25Product
0409-2253-01Product
0409-2253-25Product
Class I Terminated
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Jun 17, 2014
Oct 08, 2014
40,730 vials
Recall Profile & Regulatory Data
Event ID
68579
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 03, 2017
Product Description
Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29
Batch or Lot Expiration Information
Lot# 33-545-DD, Exp. 09/15
Affected Packages Involved in this Recall
0409-1559-18Product
0409-1559-10Product
0409-1559-19Product
0409-1559-30Product
0409-1560-18Product
0409-1560-10Product
0409-1560-19Product
0409-1560-29Product
0409-1582-18Product
0409-1582-10Product
0409-1582-19Product
0409-1582-29Product
0409-1587-50Product
0409-1610-50Product
0409-1746-70Product
0409-1746-10Product
0409-1746-71Product
0409-1746-30Product
0409-1749-70Product
0409-1749-10Product
0409-1749-71Product
0409-1749-29Product
0409-1752-50Product
0409-1755-50Product
0409-2510-01Product
0409-2510-25Product
0409-7535-01Product
0409-7535-25Product
0409-1250-01Product
0409-1250-25Product
0409-5010-01Product
0409-5010-25Product
0409-1530-01Product
0409-1530-25Product
0409-0525-01Product
0409-0525-25Product
0409-7510-01Product
0409-7510-25Product
0409-2253-01Product
0409-2253-25Product
Class I Terminated
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Apr 21, 2014
Jun 11, 2014
85,680 vials
Recall Profile & Regulatory Data
Event ID
68048
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Mar 16, 2017
Product Description
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
Batch or Lot Expiration Information
Lot# : 34-440-DD, Exp 10/15
Affected Packages Involved in this Recall
0409-1559-18Product
0409-1559-10Product
0409-1559-19Product
0409-1559-30Product
0409-1560-18Product
0409-1560-10Product
0409-1560-19Product
0409-1560-29Product
0409-1582-18Product
0409-1582-10Product
0409-1582-19Product
0409-1582-29Product
0409-1587-50Product
0409-1610-50Product
0409-1746-70Product
0409-1746-10Product
0409-1746-71Product
0409-1746-30Product
0409-1749-70Product
0409-1749-10Product
0409-1749-71Product
0409-1749-29Product
0409-1752-50Product
0409-1755-50Product
0409-2510-01Product
0409-2510-25Product
0409-7535-01Product
0409-7535-25Product
0409-1250-01Product
0409-1250-25Product
0409-5010-01Product
0409-5010-25Product
0409-1530-01Product
0409-1530-25Product
0409-0525-01Product
0409-0525-25Product
0409-7510-01Product
0409-7510-25Product
0409-2253-01Product
0409-2253-25Product
Class I Terminated
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.
Oct 18, 2013
Mar 26, 2014
40,360 vials
Recall Profile & Regulatory Data
Event ID
66503
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 18, 2015
Product Description
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.
Batch or Lot Expiration Information
Lot# Lot 25-220-DD, Exp 1JAN2015
Affected Packages Involved in this Recall
0409-1559-18Product
0409-1559-10Product
0409-1559-19Product
0409-1559-30Product
0409-1560-18Product
0409-1560-10Product
0409-1560-19Product
0409-1560-29Product
0409-1582-18Product
0409-1582-10Product
0409-1582-19Product
0409-1582-29Product
0409-1587-50Product
0409-1610-50Product
0409-1746-70Product
0409-1746-10Product
0409-1746-71Product
0409-1746-30Product
0409-1749-70Product
0409-1749-10Product
0409-1749-71Product
0409-1749-29Product
0409-1752-50Product
0409-1755-50Product
0409-2510-01Product
0409-2510-25Product
0409-7535-01Product
0409-7535-25Product
0409-1250-01Product
0409-1250-25Product
0409-5010-01Product
0409-5010-25Product
0409-1530-01Product
0409-1530-25Product
0409-0525-01Product
0409-0525-25Product
0409-7510-01Product
0409-7510-25Product
0409-2253-01Product
0409-2253-25Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
