Clonidine HCL Injection recall: Labeling Error
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…
Why was Clonidine HCL Injection 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020;
- Product
- 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…
- Recalling firm
- X-Gen Pharmaceuticals Inc.
- Quantity
- 24,966 vials
- Distribution
- Nationwide in the USA.
- Recall date
- April 17, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)