Class III
Terminated
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.
- Company
- X-Gen Pharmaceuticals Inc.
- Recall Initiated
- March 29, 2019
- Posted
- April 17, 2019
- Recall Number
- D-1084-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 24,966 vials
- Firm Location
- Horseheads, NY, United States
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
Nationwide in the USA.
Lot / Code Info
Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020;
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