Premier Pharmacy Labs Recalls Hydromorphone Syringes Due to Sterility Concerns
Premier Pharmacy Labs is recalling 3,570 hydromorphone syringes because routine testing of other lots found microbial contamination risks.
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 and involves a risk of microbial contamination in a sterile injectable drug, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Premier Pharmacy Labs Inc is recalling 3,570 units of Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. The affected product is identified by NDC 69623-249-10 and includes lots HYD030118IJDSA, HYD030118IJDSB, HYD030118IJDSD, and HYD030118IJDSE, all with a beyond-use date of 05/30/2018.
The recall was initiated due to a lack of assurance of sterility. Microbial contamination was detected during routine testing of subsequent unreleased product lots. This issue was attributed to an interaction between the product syringe and the tamper-evident container closure, which may result in the potential introduction of microorganisms into the products.
The affected syringes were distributed nationwide in the USA. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable
- Affected units
- 3,570
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 (4)
- Lots: HYD030118IJDSA
- HYD030118IJDSB
- HYD030118IJDSD
- HYD030118IJDSE BUD: 05/30/2018
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Premier Pharmacy Labs Inc 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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