ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 1...
FDA Drug Recall #D-0943-2018 — Class II — June 12, 2018
Recall Summary
| Recall Number | D-0943-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 12, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Avella of Deer Valley, Inc. Store 38 |
| Location | Phoenix, AZ |
| Product Type | Drugs |
| Quantity | 500 syringes |
Product Description
ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-891-61
Reason for Recall
Lack of Assurance of Sterility: Potential leakage of bags.
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Lot #: 05/10/18 2011 89161S, BUD 9/7/2018
Other Recalls from Avella of Deer Valley, Inc. Store 38
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0152-2020 | Class II | Povidone Iodine, 5% Ophthalmic Solution, 5 mL p... | Sep 18, 2019 |
| D-1308-2019 | Class II | Bevacizumab 2.5 mg/0.1 mL, packaged in a Prefil... | May 3, 2019 |
| D-1000-2019 | Class II | MAGnesium 2 gm sulfate, added to NS 50 mL, Ster... | Feb 8, 2019 |
| D-0999-2019 | Class II | MAGnesium 2gm sulfate, added to D5W 50 mL, Volu... | Feb 8, 2019 |
| D-0998-2019 | Class II | MAGnesium 1gm sulfate, added to D5W 50 mL, Volu... | Feb 8, 2019 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
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.