HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx
Summary
The FDA issued a Class II for HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration by SCA Pharmaceuticals, LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0408-2024
Action Date
2024-04-03
Status
Terminated
Category
drug
Product Description
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17, Bar Code 7004030317
Lot/Code Info: Lot #: 1223048491 Exp 11/21/23
Quantity Affected: 399 syringes
Reason for Recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-09
Company
Windsor, CT
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 69 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
SCA Pharmaceuticals, LLC has 32 FDA actions in our database, including 32 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 (SCA Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SCA Pharmaceuticals, LLC have FDA actions?
SCA Pharmaceuticals, LLC has 32 FDA actions in our database, including 32 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0408-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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