Ipratropium Bromide And Albuterol Sulfate Solution
FDA Recall NDC 0487-0201
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Ipratropium Bromide And Albuterol Sulfate (NDC 0487-0201). A significant event, classified as Class III, was initiated on Apr 13, 2022 by Nephron Pharmaceuticals Corporation. 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 III Terminated
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
56 pouches
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class III
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
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count (NDC 0487-0201-03), b) 60-count (NDC 0487-0201-60), Rx only, MFG: Nephron Pharma
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
0487-0201-01Product
0487-0201-02Product
0487-0201-03Product
0487-0201-60Product
August 2015 Class II Recall: Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Recall Number
Class II Terminated
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Aug 21, 2015
Oct 21, 2015
a) 85,248 cartons and b) 35,292 cartons
Recall Profile & Regulatory Data
Event ID
72099
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Nephron Pharmaceuticals Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 10, 2017
Product Description
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL
Batch or Lot Expiration Information
Lot# a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016
Affected Packages Involved in this Recall
0487-0201-01Product
0487-0201-02Product
0487-0201-03Product
0487-0201-60Product
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.
