Premier Pharmacy Labs Recalls Phenylephrine Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling 1,040 syringes of Phenylephrine HCL injection nationwide because FDA inspections found insufficient environmental controls that may compromise sterility.
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 involving significant risks such as lack of sterility assurance in injectable medications are categorized as Severe.
Plain-English summary
Premier Pharmacy Labs Inc is recalling 1,040 syringes of Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), 10mL Single-Dose Syringe. The product is distributed nationwide in the USA. The recall affects 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 can result in a lack of sterility assurance for the medication.
Healthcare providers and patients should stop using the affected product and contact their pharmacist or the recalling firm for further instructions. The product is prescription-only.
The recalled product
- Product
- Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-236-16, barcode 8 69623 23616 2.
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable Medication
- Affected units
- 1,040
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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