PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syrin
Summary
The FDA issued a Class II for PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentrati by SCA Pharmaceuticals, LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0414-2024
Action Date
2024-04-03
Status
Terminated
Category
drug
Product Description
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-12, Bar Code 70004081012
Lot/Code Info: Lot #: 1223045536 Exp 12/06/23; 1223045710 Exp 12/10/23; 1223046574 Exp 01/12/24; 1223047579 Exp 02/21/24; 1223047764 Exp 03/06/24; 1223048363 Exp 03/30/24; 1223048364 Exp 03/30/24; 1223048566 Exp 04/06/24; 1223048573 Exp 04/07/24; 1223048574 Exp 04/07/24; 1223048643 Exp 04/11/24; 1223048697 Exp 04/12/24; 1223048742 Exp 04/13/24 Expanded lots#: 1223048065, Exp 04/06/2024; 1223048395, 1223048397, Exp 03/27/2024; 1223049980, Exp 06/05/2024
Quantity Affected: 33,072 syringes; expanded 9,041 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-0414-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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