Premier Pharmacy Labs Recalls Naloxone HCL Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling Naloxone HCL Preserved Injection because FDA inspections found insufficient environmental controls and lack of process validations, raising concerns about 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 and involves a sterile injection product where a lack of sterility assurance poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Premier Pharmacy Labs Inc is recalling Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only. The product is identified by NDC 69623-235-39 and barcode 6 69623 23539 0. The recall includes 6 vials per unit and covers all lots remaining within their expiry dates.
The recall was initiated following an FDA inspection that identified insufficient environmental controls, potential cross-contamination, and a lack of product-specific process validations. These deficiencies may result in a lack of sterility assurance for the medication. The agency has classified this recall as Class II.
The product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-235-39, barcode 6 69623 23539 0.
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable Medication
- Affected units
- 6
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 (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 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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