Home / Recalls / Specialty Medicine Compounding Pharmacy / D-432-2014

D-432-2014 Class II Terminated

Recalled by Specialty Medicine Compounding Pharmacy — South Lyon, MI

Recall Details

Product Type
Drugs
Report Date
January 22, 2014
Initiation Date
October 19, 2013
Termination Date
September 22, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
186 mL

Product Description

Multitrace-4 pediatric injection ( zinc sulfate usp granular heptahydrate, cupric sulfate pentahydrate usp, manganese sulfate monohydrate usp, chromium chloride hexahydrate), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Reason for Recall

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Distribution Pattern

Hospitals, clinics, physicians, and patients in the Michigan area only.

Code Information

All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 09242013@10, 07012013@12, 07092013@14, 08132013@22, 08282013@1

Other recalls by Specialty Medicine Compounding Pharmacy

  • D-412-2014 Class II — Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 mL, Rx only, Specialty Medic (October 19, 2013)
  • D-414-2014 Class II — Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac (October 19, 2013)
  • D-455-2014 Class II — VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 mL PREF SYRINGE, Rx only, S (October 19, 2013)
  • D-431-2014 Class II — METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTAB (October 19, 2013)
  • D-423-2014 Class II — Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pha (October 19, 2013)
  • D-440-2014 Class II — Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 35 (October 19, 2013)
  • D-442-2014 Class II — Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compo (October 19, 2013)
  • D-428-2014 Class II — LIDOCAINE/SODIUM CHL* 0.4 %/18 % INJECTABLE; all sizes, Rx only, Specialty Medic (October 19, 2013)
  • D-417-2014 Class II — DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine (October 19, 2013)
  • D-459-2014 Class II — DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Trane (October 19, 2013)