Premier Pharmacy Labs recalls

Premier Pharmacy Labs appears in 24 official U.S. recall notices indexed by RecallRadar, most recently on 2019-07-03.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Week…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• 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,…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Contains Sulfites*, 10mL Single-Dose Syringe, Rx only, Premier…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613,…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki W…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercia…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy La…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 826…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Co…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharma…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 mL Dropper Bottle, Rx only, Premier Pharmacy Labs, 8265 Comm…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• 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 Wache…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 3…
  FDA Drug · Class II · 2019-07-03 · Premier Pharmacy Labs
  Reason: 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.
• 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
  FDA Drug · Class II · 2018-05-02 · Premier Pharmacy Labs
  Reason: Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which…
• Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613
  FDA Drug · Class II · 2018-05-02 · Premier Pharmacy Labs
  Reason: Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which…
• Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613
  FDA Drug · Class II · 2018-05-02 · Premier Pharmacy Labs
  Reason: Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which…
• NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe
  FDA Drug · Class II · 2018-05-02 · Premier Pharmacy Labs
  Reason: Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which…
• Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee,…
  FDA Drug · Class II · 2018-02-07 · Premier Pharmacy Labs
  Reason: Labeling: Label Error on Declared Strength
• Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Injectable Hospital/Office Use Only Compounded by: Premier Pharma…
  FDA Drug · Class II · 2017-12-27 · Premier Pharmacy Labs
  Reason: Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.