Medications & Supplements/Prescription Drugs

SCA Pharmaceuticals: Ephedrine Sulfate Syringes Recalled for Missing Lot and Expiration Date

Agency Publication Date: January 5, 2018

Summary

SCA Pharmaceuticals is recalling 1,248 units of Ephedrine sulfate (ephedrine sulfate) 5 mg/mL in 0.9% Sodium Chloride 10 mL single-dose syringes. The recall was initiated because the product labels were missing both the lot number and the beyond-use (expiration) date. This defect prevents healthcare providers from verifying the medication's potency or identifying it in the event of a quality issue. If you have this product, you should contact your healthcare provider or pharmacist for guidance on how to return it.

Risk

The absence of a lot number and expiration date means the age and batch history of the drug cannot be verified, which may lead to the administration of medication that has lost its effectiveness or is no longer safe for use.

What You Should Do

Check your medication supply for Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride (10 mL Single Dose Syringes) with NDC 70004-0600-12.
Look for syringes that are missing a lot number and expiration date, or that match lot number 20171013@30 with an expiration date of 12/27/2017.
Contact your healthcare provider or pharmacist immediately to discuss whether the syringes in your possession are safe to use or if they need to be replaced.
Return any unused or unlabeled product to the pharmacy or place of purchase for a refund.
Contact SCA Pharmaceuticals directly at their Little Rock, Arkansas facility for instructions on returning affected products.
For further questions or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy return.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe (10 mL)

Model:

NDC 70004-0600-12

Recall #: D-0156-2018

Lot Numbers:

20171013@30 (Exp 12/27/2017)

20171013

Date Ranges: 12/27/2017

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78708

Status: Resolved

Manufacturer: SCA Pharmaceuticals

Manufactured In: United States

Units Affected: 1248 syringes

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication supply for Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride (10 mL Single Dose Syringes) with NDC 70004-0600-12.

Look for syringes that are missing a lot number and expiration date, or that match lot number 20171013@30 with an expiration date of 12/27/2017.

Contact your healthcare provider or pharmacist immediately to discuss whether the syringes in your possession are safe to use or if they need to be replaced.

Return any unused or unlabeled product to the pharmacy or place of purchase for a refund.

Contact SCA Pharmaceuticals directly at their Little Rock, Arkansas facility for instructions on returning affected products.

For further questions or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).