Home / Recalls / Premier Pharmacy Labs Inc / D-1420-2019

D-1420-2019 Class II Terminated

Recalled by Premier Pharmacy Labs Inc — Weeki Wachee, FL

Recall Details

Product Type
Drugs
Report Date
July 3, 2019
Initiation Date
June 18, 2019
Termination Date
October 26, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1834 irrigation vials

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide in the USA

Code Information

All lots remaining within expiry.

Other recalls by Premier Pharmacy Labs Inc

  • D-1424-2019 Class II — Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *Con (June 18, 2019)
  • D-1417-2019 Class II — Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL S (June 18, 2019)
  • D-1426-2019 Class II — Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SDV, (June 18, 2019)
  • D-1413-2019 Class II — ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, (June 18, 2019)
  • D-1414-2019 Class II — Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/ (June 18, 2019)
  • D-1425-2019 Class II — Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), 3 m (June 18, 2019)
  • D-1411-2019 Class II — Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx on (June 18, 2019)
  • D-1421-2019 Class II — Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Pre (June 18, 2019)
  • D-1415-2019 Class II — Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single- (June 18, 2019)
  • D-1427-2019 Class II — SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe, R (June 18, 2019)