Home / Recalls / Isomeric Pharmacy Solution, LLC / D-0685-2017

D-0685-2017 Class II Terminated

Recalled by Isomeric Pharmacy Solution, LLC — Salt Lake City, UT

Recall Details

Product Type
Drugs
Report Date
May 3, 2017
Initiation Date
April 6, 2017
Termination Date
August 30, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
851 vials

Product Description

Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.

Reason for Recall

Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lot #s: 09003, Exp 04/17/17; 11003, Exp 06/21/17; 11035, Exp 07/03/17; 11039, Exp 07/05/17; 12002, Exp 07/23/17; 12012, Exp 07/30/17.

Other recalls by Isomeric Pharmacy Solution, LLC

  • D-0683-2017 Class II — Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial (April 6, 2017)
  • D-0681-2017 Class II — Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vi (April 6, 2017)
  • D-0687-2017 Class II — Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalm (April 6, 2017)
  • D-0682-2017 Class II — Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vi (April 6, 2017)
  • D-0684-2017 Class II — Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, (April 6, 2017)
  • D-0686-2017 Class II — Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi- (April 6, 2017)
  • D-0518-2017 Class II — Triamcinolone 40 mg/mL 2 mL Single-Dose Vial for Injection, Preservative Free, R (March 8, 2017)
  • D-1454-2016 Class II — Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 (August 1, 2016)
  • D-1480-2016 Class II — Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multido (June 29, 2016)
  • D-0728-2016 Class III — Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial fo (February 2, 2016)