ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road,
Summary
The FDA issued a Class II for ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx onl by Central Admixture Pharmacy Services Inc. Reason: Lack of assurance of sterility: Lack of validation data for sanitization cycles.
Details
Source
Drug Recall
External ID
D-1073-2023
Action Date
2023-08-09
Status
Terminated
Category
drug
Product Description
ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6004-1
Lot/Code Info: Lot: 17-270545, Exp. 7/16/2023; 17-270614, Exp. 7/17/2023; 17-270885, 17-270897, Exp. 7/20/2023; 17-270980, 17-270992, Exp. 7/23/2023; 17-271268, Exp. 7/26/2023; 17-271338, Exp. 7/27/2023; 17-271426, 17-271428, Exp. 7/30/2023; 17-271691, Exp. 8/2/2023; 17-271843, Exp. 8/6/2023; 17-271963, Exp. 8/8/2023; 17-272136, Exp. 8/10/2023; 17-272215, Exp. 8/13/2023; 17-272304, Exp. 8/14/2023; 17-272379, Exp. 8/15/2023; 17-272462, Exp. 8/16/2023; 17-272641, Exp. 8/20/2023; 17-272698, Exp. 8/21/2023; 17-273602, 17-273627, Exp. 9/5/2023; 17-273883, Exp. 9/10/2023.
Quantity Affected: 8,942 syringes
Reason for Recall
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-17
Company
San Diego, CA
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 171 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-1073-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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