Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufacture...
FDA Drug Recall #D-1084-2019 — Class III — March 29, 2019
Recall Summary
| Recall Number | D-1084-2019 |
| Classification | Class III — Low risk |
| Date Initiated | March 29, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | X-Gen Pharmaceuticals Inc. |
| Location | Horseheads, NY |
| Product Type | Drugs |
| Quantity | 24,966 vials |
Product Description
Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals, Big Flats, NY 14814, NDC 39822-2000-1.
Reason for Recall
Labeling: Label Error on Declared Strength: Side carton panel incorrectly lists the concentration as "500 mcg Clonidine Hydrochloride" rather than the correct concentration of "100 mcg Clonidine Hydrochloride" per mL.
Distribution Pattern
Nationwide in the USA.
Lot / Code Information
Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020;
Other Recalls from X-Gen Pharmaceuticals Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0434-2024 | Class III | Cyclophosphamide for Injection, USP, 1g/vial, L... | Apr 2, 2024 |
| D-0433-2024 | Class III | Cyclophosphamide for Injection, USP, 500mg/vial... | Apr 2, 2024 |
| D-0328-2021 | Class II | Neomycin Sulfate Tablets, USP 500mg, Rx Only, 1... | Mar 19, 2021 |
| D-0519-2020 | Class III | Levetiracetam Injection, 500 mg/5mL, 10 single-... | Oct 11, 2019 |
| D-1059-2017 | Class II | Nystatin Topical Powder, USP, 100,000 USP units... | May 17, 2017 |
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.