Premier Pharmacy Labs Recalls Isoproterenol Bags Due to Sterility Concerns
Premier Pharmacy Labs is recalling 606 bags of Isoproterenol HCL in D5W because FDA inspections found insufficient environmental controls that may compromise sterility.
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 the hazard involves a lack of sterility assurance in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Premier Pharmacy Labs Inc is recalling 606 bags of Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag. The product is prescription-only and was distributed nationwide in the USA. The recall includes 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 sterile injectable product.
Healthcare providers and patients should stop using the recalled product. Consumers should contact their healthcare provider or pharmacist for guidance on alternative treatments or replacements.
The recalled product
- Product
- Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-230-57, barcode 0 69623 23057 7.
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable
- Affected units
- 606
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.
See all 18 products in this recall →Related recalls
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