PharMEDium Recalls Hydromorphone Syringes Due to Sterility Assurance Issues
PharMEDium Services is recalling 46 lots of Hydromorphone in 0.9% Sodium Chloride HCl syringes due to a lack of sterility assurance.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination.
Plain-English summary
PharMEDium Services, LLC is recalling 46 lots of various products, including Hydromorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe. The recall is being conducted because of a lack of sterility assurance.
The affected product is distributed nationwide in the US. The specific lot codes and expiration dates for the recalled Hydromorphone syringes are listed in the source data, including codes such as 193510022D, 193510023D, 193580012D, 193600013D, 193640016D, 193530020D, 193540023D, and 193540026D.
Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots. They should contact the manufacturer or their healthcare provider for further instructions on how to return or dispose of the product.
The recalled product
- Product
- HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per 30 mL, 30 mL in a 35 mL Monoject Barrel Syringe, PharMEDium Services LLC 913 M. Davis Ave Cleveland, MS. NDC 61553-166-44
- Manufacturer
- PharMEDium Services, LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 1,840
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by PharMEDium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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