Reported Jul 3, 2019 · Terminated
Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265…
Premier Pharmacy Labs Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Premier Pharmacy Labs Inc · 8265 Commercial Way · Weeki Wachee, FL · 34613-4511
Is this the product you have?
Sodium Bicarbonate INJ 8.4%50 mEq/50mL (84mg/mL) (1mEq/mL)50mL Sterile SDVRx onlyPremier Pharmacy Labs8265 Commercial WayWeeki WacheeFL 34613
- NDC
69623-232-39barcode 8 69623 23239 3
- Lot codes and dates
- All lots remaining within expiry.
- Amount recalled
- 13150 vials
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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