PharMEDium Recalls Hydromorphone Injection Due to Potency Failure
PharMEDium Services is recalling 499 syringes of Hydromorphone HCl injection because the product failed potency specifications.
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 499 syringes of Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection. The recall was initiated because the product produced an out-of-specification result for potency, meaning the drug concentration did not meet required standards.
The affected product is identified by Lot Number 172820134M and has an expiration date of 01/18. The product was distributed in California and Illinois.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packaged in syringes, Rx Only , PharMEDium Services, LLC. 913 N. Davis Ave Cleveland, MS 38732, NDC 61553-352-40
- Manufacturer
- PharMEDium Services, LLC.
- Category
- Drug — Injection
- Hazard
- Affected units
- 499
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 (2)
- Lot#: 172820134M
- Exp 01/18
Distribution
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