Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley He
Summary
The FDA issued a Class II for Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx by Hikma Pharmaceuticals USA Inc.. Reason: The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot..
Details
Source
Drug Recall
External ID
D-0392-2024
Action Date
2024-03-27
Status
Ongoing
Category
drug
Product Description
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01
Lot/Code Info: Lot #: 052001, 052003, Exp. Date 11/2024; 023012, 023014, Exp. Date 08/2024
Quantity Affected: 22,644 ampuls
Reason for Recall
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-12
Company
Cherry Hill, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 47 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Hikma Pharmaceuticals USA Inc. has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hikma Pharmaceuticals USA Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hikma Pharmaceuticals USA Inc. have FDA actions?
Hikma Pharmaceuticals USA Inc. has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0392-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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