Cefazolin Sodium Solution
FDA Recall NDC 0264-3105
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Cefazolin Sodium (NDC 0264-3105). A significant event, classified as Class II, was initiated on Apr 13, 2022 by B. Braun Medical Inc.. The reported reason for this action was: "cGMP deviations: Temperature abuse"
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
Class II Terminated
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
39 cases
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex container, Rx only, MFG: B. Braun Medical Inc., NDC 0264-3105-11
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
0264-3103-11Product
0264-3105-11Product
0264-3107-11Product
Class II Terminated
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
26 cases
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex container, Rx only, MFG: B. Braun Medical Inc., NDC 0264-3103-11
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
0264-3103-11Product
0264-3105-11Product
0264-3107-11Product
Class I Terminated
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Nov 21, 2013
May 07, 2014
136,392 units
Recall Profile & Regulatory Data
Event ID
66913
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico and Spain
Termination Date
Dec 04, 2014
Product Description
Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-11
Batch or Lot Expiration Information
Lot# H2S725, H2S726, Exp 07/14; H3D724, Exp 11/14; H3E724, Exp 12/14
Lot# H3H507, Exp 01/15
Affected Packages Involved in this Recall
0264-3103-11Product
0264-3105-11Product
0264-3107-11Product
Class I Terminated
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Nov 21, 2013
May 07, 2014
42,576 units
Recall Profile & Regulatory Data
Event ID
66913
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
B. Braun Medical Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico and Spain
Termination Date
Dec 04, 2014
Product Description
Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11
Batch or Lot Expiration Information
Lot# H2S723, Exp 07/14; H3H711, Exp 01/15
Affected Packages Involved in this Recall
0264-3103-11Product
0264-3105-11Product
0264-3107-11Product
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.
