PharMEDium Recalls Hydromorphone Syringes Due to Sulfite Mislabeling
PharMEDium Services is recalling 28,140 hydromorphone syringes because the product is labeled as sulfite-free but contains sulfites.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score.
Plain-English summary
PharMEDium Services, LLC is recalling 28,140 syringes of Hydromorphone HCl in 0.9% sodium chloride, 0.5mg per mL, 1 mL in 3mL BD Syringe. The recall was initiated because the product is labeled as sulfite-free, but it is produced with a raw material that contains sulfite.
The affected product is distributed nationwide within the United States. The recall covers specific lots with expiration dates ranging from June 9, 2019, to August 1, 2019. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
Consumers and healthcare providers should stop using the affected syringes and contact PharMEDium Services or their healthcare provider for further instructions. Patients with sulfite sensitivity should be particularly cautious and consult their healthcare provider regarding alternative treatments.
The recalled product
- Product
- 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
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 28,140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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