Multi-event May 2017 FDA Recall Milrinone Lactate In Dextrose by Baxter Healthcare Corporation
This Multi-event Class II drug recall was voluntarily initiated by Baxter Healthcare Corporation on May 15, 2017 for the product Milrinone Lactate In Dextrose. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in US and foreign countries: United Arab Emirates, Colombia, and Canada and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0788-2017
Lack of assurance of sterility: customer complaints received for the presence of leaks.
05-15-2017
05-24-2017
113,590 bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Baxter Healthcare Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US and foreign countries: United Arab Emirates, Colombia, and Canada
08-10-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48
Batch or Lot Expiration Information
Lot# : P344028/P344028A, Exp 12/31/17; P352377, Exp 8/31/18; P348136, Exp 4/30/18
Affected Packages Involved in this Recall
Recall Number: D-0789-2017
Lack of assurance of sterility: customer complaints received for the presence of leaks.
05-15-2017
05-24-2017
90,450 bags
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Baxter Healthcare Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US and foreign countries: United Arab Emirates, Colombia, and Canada
08-10-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48
Batch or Lot Expiration Information
Lot# : P342485, Exp 11/30/17; P344408, Exp 12/31/17
