PharMEDium Recalls Hydromorphone Syringes Due to Potency Issues
PharMEDium Services is recalling 2,800 hydromorphone syringes nationwide because some units were found to be superpotent or subpotent.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe).
Plain-English summary
PharMEDium Services, LLC is recalling 2,800 syringes of Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride. The recall affects 1 mL total volume units packaged in 3 mL syringes. The product is distributed nationwide.
The recall was initiated because the product was found to be superpotent and subpotent. This means the concentration of the active ingredient in some syringes was higher or lower than the labeled amount.
The affected lot numbers are 180820005D (expiration 6/21/2018), 180990007D (expiration 7/8/2018), and 181000020D (expiration 7/9/2018). Healthcare providers and patients should stop using these specific lots and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2,800
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 (6)
- Lot numbers: 180820005D
- exp 6/21/2018
- 180990007D
- exp 7/8/2018
- and 181000020D
- exp 7/9/2018
Distribution
Distributed nationwide across the United States.
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