Premier Pharmacy Labs Recalls Isoproterenol HCL Bags Due to Sterility Concerns
Premier Pharmacy Labs is recalling 40 bags of Isoproterenol HCL in D5W due to FDA findings of insufficient environmental controls and lack of sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. 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 lack of sterility assurance in a sterile injectable product, which poses a significant risk of infection and potential hospitalization.
Plain-English summary
Premier Pharmacy Labs Inc is recalling 40 bags of Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag. The product is prescription-only and was distributed nationwide in the USA. The recall covers all lots remaining within their expiry dates.
The recall was initiated after an FDA inspection 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 affected medication.
Healthcare providers and patients should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-107-57, barcode 3 69623 10757 3.
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable Medication
- Affected units
- 40
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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