Premier Pharmacy Labs Recalls Sodium Bicarbonate Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling 13,150 vials of Sodium Bicarbonate Injection 8.4% nationwide because FDA inspections found insufficient environmental controls and lack of 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 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 13,150 vials of Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV. 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 sterile injectable product.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions. The product is identified by NDC 69623-232-39 and barcode 8 69623 23239 3.
The recalled product
- Product
- Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-232-39, barcode 8 69623 23239 3.
- Manufacturer
- Premier Pharmacy Labs Inc
- Category
- Drug — Injectable
- Affected units
- 13,150
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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