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.
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.
Lot numbers, UPCs & expiration codes
Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020;
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1084-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 29, 2019
- FDA report date
- Apr 17, 2019
- Quantity
- 24,966 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- X-Gen Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1084-2019, exactly as published.
Show all FDA fields
- City
- Horseheads
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 82504
- Address
- 300 Daniel Zenker Dr
- Code information
- Lots #: PMXA1917, Exp 09/2020; PMXA1937, PMXA1938, Exp 11/2020;
- Postal code
- 14845-1014
- Report date
- Apr 17, 2019
- Product type
- Drugs
- Recall number
- D-1084-2019
- Classification
- Class III
- Recalling firm
- X-Gen Pharmaceuticals Inc.
- Product quantity
- 24,966 vials
- Termination date
- Jun 2, 2021
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 29, 2019
- Initial firm notification
- Letter
- Center classification date
- Apr 8, 2019