Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106
Summary
The FDA issued a Class II for Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6 by Central Admixture Pharmacy Services, Inc.. Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile..
Details
Source
Drug Recall
External ID
D-0753-2023
Action Date
2023-05-31
Status
Terminated
Category
drug
Product Description
Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911.
Lot/Code Info: Lot # 37-870983, Exp 06/10/2023; 37-879653, 37-879654, Exp 07/16/2023; 37-883186, Exp 07/29/2023; 37-888533, Exp 08/20/2023; 37-893416, Exp 09/09/2023
Quantity Affected: 1516 bags
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Distribution
Nationwide in the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-28
Company
Allentown, PA
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 216 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Central Admixture Pharmacy Services, Inc. has 307 FDA actions in our database, including 307 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 (Central Admixture Pharmacy Services, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Central Admixture Pharmacy Services, Inc. have FDA actions?
Central Admixture Pharmacy Services, Inc. has 307 FDA actions in our database, including 307 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0753-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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