Home / Recalls / Premier Pharmacy Labs Inc / D-0251-2018

D-0251-2018 Class II Terminated

Recalled by Premier Pharmacy Labs Inc — Weeki Wachee, FL

Recall Details

Product Type
Drugs
Report Date
February 7, 2018
Initiation Date
January 11, 2018
Termination Date
June 4, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
193 vials

Product Description

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.

Reason for Recall

Labeling: Label Error on Declared Strength

Distribution Pattern

Nationwide.

Code Information

Lot: MIT100217SVDS BUD: 03/01/2018

Other recalls by Premier Pharmacy Labs Inc

  • D-1421-2019 Class II — Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, Pre (June 18, 2019)
  • D-1412-2019 Class II — Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier P (June 18, 2019)
  • D-1428-2019 Class II — SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syringe (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-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-1420-2019 Class II — Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only, P (June 18, 2019)
  • D-1415-2019 Class II — Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single- (June 18, 2019)