FDA (Drugs) recall action 83146

Premier Pharmacy Labs Inc recalled 18 products on 2019-07-03

The FDA (Drugs) publishes a recall like this one as 18 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 18 pages.

Products: 18
Announced: 2019-07-03
Critical: 0
Units: 40,220

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–18 of 18

SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Succinylcholine Chloride Syringes for Sterility Concerns
Premier Pharmacy Labs is recalling 6,423 syringes of Succinylcholine Chloride due to FDA findings of insufficient environmental controls and lack of sterility assurance.
Product
SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-15, barcode 0 69623 23915 0.
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SevereFDA (Drugs)··2019-07-03
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.
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.
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0 states
SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Mitomycin Irrigation Due to Sterility Concerns
Premier Pharmacy Labs is recalling 1,834 vials of Mitomycin Preservative Free Irrigation because FDA inspections found insufficient environmental controls that may compromise sterility.
Product
Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35, barcode 5 69623 16035 0.
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SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Isoproterenol HCL Bags Due to Sterility Concerns
Premier Pharmacy Labs is recalling 1,235 bags of Isoproterenol HCL in D5W nationwide because FDA inspections found insufficient environmental controls and lack of sterility assurance.
Product
Isoproterenol HCL in D5W (Non 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: 69623-240-57, barcode 0 69623 24057 7.
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SevereFDA (Drugs)··2019-07-03
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.
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.
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0 states
SevereFDA (Drugs)··2019-07-03
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.
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.
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SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Dexamethasone Syringes Due to Sterility Concerns
Premier Pharmacy Labs is recalling 86 syringes of Dexamethasone Sodium Phosphate due to potential sterility issues found during an FDA inspection.
Product
Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-252-10, barcode 0 69623 25210 4.
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SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Naloxone HCL Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling Naloxone HCL Preserved Injection because FDA inspections found insufficient environmental controls and lack of process validations, raising concerns about sterility assurance.
Product
Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-235-39, barcode 6 69623 23539 0.
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0 states
SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Brilliant Blue Ophthalmic Injection for Sterility Concerns
Premier Pharmacy Labs is recalling 578 vials of Brilliant Blue Ophthalmic Injection due to a lack of assurance of sterility identified during an FDA inspection.
Product
Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-211-31, barcode 2 69623 21131 0.
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SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Riboflavin 5-Phosphate Sodium Ophthalmic Solution
Premier Pharmacy Labs is recalling 125 bottles of Riboflavin 5-Phosphate Sodium Ophthalmic Solution due to a lack of assurance of sterility.
Product
Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-106-61, barcode 1 69623 10661 9.
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0 states
SevereFDA (Drugs)··2019-07-03
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.
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.
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SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Lidocaine and Phenylephrine Injection Vials
Premier Pharmacy Labs is recalling 323 vials of Lidocaine 0.5%/Phenylephrine 0.75% Injection due to a lack of sterility assurance identified during an FDA inspection.
Product
Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-176-31, barcode 6 69623 17631 0.
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SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Succinylcholine Chloride Syringes for Sterility Concerns
Premier Pharmacy Labs is recalling 1,721 syringes of Succinylcholine Chloride due to FDA findings of insufficient environmental controls and lack of sterility assurance.
Product
SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-239-16, barcode 9 69623 23916 0.
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SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Atropine Sulfate Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling 745 syringes of Atropine Sulfate Injection because FDA inspections found insufficient environmental controls that may compromise sterility.
Product
Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-131-12, barcode 0 69623 13112 6.
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SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Neostigmine Methylsulfate Syringes for Sterility Concerns
Premier Pharmacy Labs is recalling Neostigmine Methylsulfate syringes nationwide due to FDA findings of insufficient environmental controls and lack of sterility assurance.
Product
Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-234-15, barcode 5 69623 23415 0.
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SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Orphenadrine Citrate Syringes Due to Sterility Concerns
Premier Pharmacy Labs is recalling 4,363 syringes of Orphenadrine Citrate Sterile Injectable Solution because FDA inspections found insufficient environmental controls that may compromise sterility.
Product
Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-104-10, barcode 7 69623 10410 5.
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SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Chlorpromazine Injection Due to Sterility Concerns
Premier Pharmacy Labs is recalling 824 vials of Chlorpromazine HCL Injection because an FDA inspection found insufficient environmental controls that may compromise sterility.
Product
ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4.
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SevereFDA (Drugs)··2019-07-03
Premier Pharmacy Labs Recalls Droperidol Syringes Due to Sterility Concerns
Premier Pharmacy Labs is recalling 2,315 syringes of Droperidol Injectable Sterile Solution because FDA inspections found insufficient environmental controls and lack of sterility assurance.
Product
Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-185-10, barcode 0 69623 18510 5.
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