Home / Recalls / Isomeric Pharmacy Solution, LLC / D-1454-2016

D-1454-2016 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
August 10, 2016
Initiation Date
August 1, 2016
Termination Date
August 1, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,331 vials

Product Description

Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension, 7 mg/ mL,10 mL Multi-Dose vial for injection, Rx Only, Isomeric Pharmacy Solution, 2401 Foothill Dr., Salt Lake City, UT 84109

Reason for Recall

Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot# 03037, Exp 8/17/16; 03042, 03043, Exp 8/31/16; 04043, Exp 9/29/16; 04047, 04048, Exp 10/1/16; 04052, 04053, Exp10/2/16; 05042, Exp 10/29/16; 05046, Exp 11/2/16; 05048, 05049, Exp 11/3/16; 05050 Exp 11/4/16

Other recalls by Isomeric Pharmacy Solution, LLC

  • D-0682-2017 Class II — Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vi (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-0681-2017 Class II — Methylprednisolone Acetate 40 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-0687-2017 Class II — Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalm (April 6, 2017)
  • D-0683-2017 Class II — Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial (April 6, 2017)
  • D-0685-2017 Class II — Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL (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-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)