ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC...
FDA Drug Recall #D-1548-2014 — Class II — May 16, 2014
Recall Summary
| Recall Number | D-1548-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 16, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | US Compounding Inc |
| Location | Conway, AR |
| Product Type | Drugs |
| Quantity | 762 Syringes |
Product Description
ePHEDrine Sulfate Injection, USP 25 mg/5 mL (5 mg/mL) Single Use 5 mL Syringe, For IV, IM, or SC injection, Preservative Free, For Office/Hospital Use Only, Protect from Light, 62295-3084-05, US Compounding Pharmacy, Conway, AR 800-718-3588
Reason for Recall
Labeling: Label Error on Declared Strength; The outer light protective bags, where the ephedrine sulfate injection syringes are stored, were mislabeled with 25 mg/mL in big font and 5 mg/mL in small font, however, the actual syringes were correctly labeled as 25 mg/5 mL.
Distribution Pattern
Nationwide
Lot / Code Information
Lot# 20142104@30 USE BY: 10/18/2014
Other Recalls from US Compounding Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0223-2021 | Class III | Succinylcholine Chloride PF Inj. 200 mg/10 mL, ... | Dec 16, 2020 |
| D-0175-2021 | Class III | Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 ... | Nov 25, 2020 |
| D-0508-2019 | Class II | Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Us... | Jan 29, 2019 |
| D-0482-2019 | Class II | LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl ... | Jan 24, 2019 |
| D-0219-2017 | Class I | Docusate Oral 10 mg/mL Oral Syringe, packaged i... | Jul 25, 2016 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.