Multi-event February 2024 FDA Recall Rocuronium Bromide by Mckesson Medical-surgical Inc. Corporate Office

This Multi-event Class II drug recall was voluntarily initiated by Mckesson Medical-surgical Inc. Corporate Office on February 7, 2024 for the product Rocuronium Bromide. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to three direct accounts in NM, AZ and UT. and the recall is currently terminated.

Reported Recall Events

D-0373-2024 TERMINATED D-0372-2024 TERMINATED D-0371-2024 TERMINATED

Recall Number: D-0373-2024

Reason for Recall
cGMP Deviations: Products were stored outside the drug label specifications.
Initiated
02-07-2024
Reported
03-20-2024
Quantity
70 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93935
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to three direct accounts in NM, AZ and UT.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-14-2024
Product Description About Product Description
Full technical description of the product.
Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10

Batch or Lot Expiration Information

Lot# 567951

Recall Number: D-0372-2024

Reason for Recall
cGMP Deviations: Products were stored outside the drug label specifications.
Initiated
02-07-2024
Reported
03-20-2024
Quantity
70 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93935
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to three direct accounts in NM, AZ and UT.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-14-2024
Product Description About Product Description
Full technical description of the product.
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01

Batch or Lot Expiration Information

Lot# 519644

Recall Number: D-0371-2024

Reason for Recall
cGMP Deviations: Products were stored outside the drug label specifications.
Initiated
02-07-2024
Reported
03-20-2024
Quantity
70 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93935
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to three direct accounts in NM, AZ and UT.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-14-2024
Product Description About Product Description
Full technical description of the product.
Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10

Batch or Lot Expiration Information

Lot# 1064081

Affected Packages Involved in this Recall

55150-225-05 Rocuronium Bromide
55150-226-10 Rocuronium Bromide