Why it was recalled
Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
Product description
Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78
Lot numbers, UPCs & expiration codes
Lot #: 190670030D,190670031D, 190670032D, 190670033D, Exp. 6/9/2019; 190710015D, 190710016D, 190710017D, 190710018D, 190710019D, Exp. 6/11/2019; 190730028D, 190730029D, 190730030D, Exp. 6/13/2019; 190740018D, Exp.6/16/2019; 190770028D, 190770029D, Exp. 6/17/2019; 190780027D, 190780028D, 190780029D, Exp. 6/18/2019; 190790030D, Exp. 6/19/2019; 190800012D, 190800013D, 190800014D, 190800015D, 190800016D, Exp.6/20/2019; 190810033D, 190810034D, 190810035D,190810036D, Exp.6/23/2019; 190840002D, Exp. 6/24/2019; 190870008D, Exp. 6/27/2019; 190910015D, Exp. 7/1/2019; 190980033D, Exp. 7/8/2019; 190990017D, 190990030D, Exp. 7/9/2019; 191000035D, Exp. 7/10/2019; 191010008D,191010009D, 191010010D, Exp. 7/11/2019; 191050002D, Exp.7/15/2019; 191120002D, Exp.7/22/2019; 191160001D, Exp. 7/28/2019; 191210020D, 191210021D, 191210022D, Exp.7/31/2019; 191220017D, Exp.8/1/2019.
Where it was sold
Nationwide within the United States
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-1488-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jun 7, 2019
- FDA report date
- Jul 10, 2019
- Quantity
- 28,140 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- PharMEDium Services, LLC
Original FDA data
Every field from FDA enforcement report D-1488-2019, exactly as published.
Show all FDA fields
- City
- Dayton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83207
- Address
- 36 Stults Rd
- Code information
- Lot #: 190670030D,190670031D, 190670032D, 190670033D, Exp. 6/9/2019; 190710015D, 190710016D, 190710017D, 190710018D, 190710019D, Exp. 6/11/2019; 190730028D, 190730029D, 190730030D, Exp. 6/13/2019; 190740018D, Exp.6/16/2019; 190770028D, 190770029D, Exp. 6/17/2019; 190780027D, 190780028D, 190780029D, Exp. 6/18/2019; 190790030D, Exp. 6/19/2019; 190800012D, 190800013D, 190800014D, 190800015D, 190800016D, Exp.6/20/2019; 190810033D, 190810034D, 190810035D,190810036D, Exp.6/23/2019; 190840002D, Exp. 6/24/2019; 190870008D, Exp. 6/27/2019; 190910015D, Exp. 7/1/2019; 190980033D, Exp. 7/8/2019; 190990017D, 190990030D, Exp. 7/9/2019; 191000035D, Exp. 7/10/2019; 191010008D,191010009D, 191010010D, Exp. 7/11/2019; 191050002D, Exp.7/15/2019; 191120002D, Exp.7/22/2019; 191160001D, Exp. 7/28/2019; 191210020D, 191210021D, 191210022D, Exp.7/31/2019; 191220017D, Exp.8/1/2019.
- Postal code
- 08810
- Report date
- Jul 10, 2019
- Product type
- Drugs
- Recall number
- D-1488-2019
- Classification
- Class I
- Recalling firm
- PharMEDium Services, LLC
- Product quantity
- 28,140 syringes
- Termination date
- Jun 2, 2020
- Reason for recall
- Incorrect Product Formulation; Firm's customer resource center (CRC) statement indicates that the product is sulfite free, however the product is produced with a raw material that contains sulfite
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe, PharMEDium 913 N Davis Ave Cleveland, MS 38732, 800-523-7749, NDC 61553-352-78
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jun 7, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 16, 2019