X-Gen Pharmaceuticals Inc. recalls Clonidine HCL Injection, 1000 mcg/10mL (100 mcg/mL), 10 ML Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceu…
- Recall date
- March 29, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1084-2019
- FDA classification
- Class III
- Brand / firm
- X-Gen Pharmaceuticals Inc.
- Sold / distributed
- Nationwide in the USA.
Why it was recalled
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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