Home / Recalls / Beacon Hill Medical Pharmacy, P.C. / D-1011-2013

D-1011-2013 Class II Terminated

Recalled by Beacon Hill Medical Pharmacy, P.C. — Southfield, MI

Recall Details

Product Type
Drugs
Report Date
September 18, 2013
Initiation Date
July 26, 2013
Termination Date
July 18, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

Reason for Recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Distribution Pattern

USA nationwide

Code Information

02082013@9, 06102013@16

Other recalls by Beacon Hill Medical Pharmacy, P.C.

  • D-1016-2013 Class II — CALCIUM EDTA 200 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE (July 26, 2013)
  • D-943-2013 Class II — CALCIUM CHLORIDE 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ U (July 26, 2013)
  • D-990-2013 Class II — PROCAINE P/F 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ON (July 26, 2013)
  • D-993-2013 Class II — PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP, all presentations, FOR INTRAVENO AND SQ U (July 26, 2013)
  • D-957-2013 Class II — ESTRIOL 5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, (July 26, 2013)
  • D-980-2013 Class II — MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/ML INJECTABLE, all presentat (July 26, 2013)
  • D-938-2013 Class II — ARGININE (R-GENE) 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ (July 26, 2013)
  • D-998-2013 Class II — SODIUM BICARBONATE PF 8.4% INJECTABLE, all presentations, FOR INTRAVENO AND SQ U (July 26, 2013)
  • D-935-2013 Class II — B-12/LIDOCAINE 25/10MG/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STE (July 26, 2013)
  • D-953-2013 Class II — EDETATE DISODIUM 150 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ (July 26, 2013)