The Recall Desk

Manufacturer

Premier Pharmacy Labs Inc

24 recalls in our database name Premier Pharmacy Labs Inc as the manufacturing or recalling firm.

What the numbers show

Total
24
Critical
0
Severe
22
Most recent
2019-07-03

Of the 24 recalls from Premier Pharmacy Labs Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 22 (92%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–24 of 24

  • SevereFDA (Drugs)·D-1425-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1418-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1427-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1424-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1415-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1423-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1426-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1416-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1422-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1419-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1412-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1428-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1417-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1413-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1414-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1421-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1420-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1411-2019·2019-07-03

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0700-2018·2018-05-02

    Premier Pharmacy Labs Recalls Morphine Sulfate Syringes Due to Sterility Concerns

    Premier Pharmacy Labs Inc is recalling 4,192 syringes of Morphine Sulfate 4 mg/mL PF Injection due to a lack of assurance of sterility.

    Product
    Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0701-2018·2018-05-02

    Premier Pharmacy Labs Recalls Hydromorphone Syringes Due to Sterility Concerns

    Premier Pharmacy Labs is recalling 3,570 hydromorphone syringes because routine testing of other lots found microbial contamination risks.

    Product
    Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0702-2018·2018-05-02

    Premier Pharmacy Labs Recalls NeoStigmine Syringes Due to Sterility Concerns

    Premier Pharmacy Labs is recalling NeoStigmine Methylsulfate syringes because routine testing of other lots detected microbial contamination risks.

    Product
    NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0699-2018·2018-05-02

    Premier Pharmacy Labs Recalls Morphine Sulfate Injection Due to Sterility Concerns

    Premier Pharmacy Labs is recalling specific lots of Morphine Sulfate Injection because routine testing of other lots detected microbial contamination risks.

    Product
    Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0251-2018·2018-02-07

    Premier Pharmacy Labs Recalls Mitomycin Vials Due to Labeling Error

    Premier Pharmacy Labs is recalling 193 vials of Mitomycin 40 mg/mL due to a label error on the declared strength.

    Product
    Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0129-2018·2017-12-27

    Premier Pharmacy Labs Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error

    Premier Pharmacy Labs is recalling Neostigmine Methylsulfate syringes because the printed beyond-use dates exceed current stability data.

    Product
    Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharmacy Labs., Inc. 8265 Commercial Way Weeki Wachee, FL 34613, NDC# 69623-234-15
    Category
    Drug
    Distribution
    6 states