The Recall Desk

FDA (Drugs) recall action 66566

Specialty Medicine Compounding Pharmacy recalled 51 products on 2014-01-22

The FDA (Drugs) publishes a recall like this one as 51 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 51 pages.

Products
51
Announced
2014-01-22
Critical
0
Units
3,081

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 51

  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls 0.9% Sodium Chloride Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling 0.9% Sodium Chloride injectable and topical products because sterility cannot be assured after a related product was found non-sterile.

    Product
    0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 mL Injectable, b) DT-0.9% Sodium Chloride* 100 mL Drug Study - Topical, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling unexpired sterile compounded human and veterinary products because sterility cannot be assured after a related product was found non-sterile.

    Product
    DT- Tranexamic Acid* 2 gm/100 mL Drug Study -IV 100 mL injectable, DT-, DT-Tranexamic Acid* 2 gm/100 mL-Drug Study-Topical 100 mL Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Combo Eye Gel Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Combo Eye Gel because sterility cannot be assured after another product was found non-sterile in the same environment.

    Product
    Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofenac sodium 0.1%, ciprofloxacin 0.3%, phenylephrine 10%, lidocaine jelly 2%), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Hyaluronidase Recalled Due to Lack of Assurance of Sterility

    Specialty Medicine Compounding Pharmacy is recalling Hyaluronidase products because sterility cannot be assured after a related product was found non-sterile.

    Product
    Hyaluronidase, pf 100U/mL; pf 150 U/mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Phenol Injectable Recalled Due to Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Phenol, 6%, Injectable, because sterility cannot be assured after a related product was found non-sterile.

    Product
    Phenol, 6%, Injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Cyanocobalamin Injectable Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling cyanocobalamin injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Sodium Thiosulfate Injectable Recalled for Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Sodium Thiosulfate PF, 10% injectable, because sterility cannot be assured after another product was found non-sterile in the same environment.

    Product
    Sodium Thiosulfate PF, 10 % injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Sodium Phosphate Injectable Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Sodium Phosphate injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Acetylcysteine Ophthalmic Solution

    Specialty Medicine Compounding Pharmacy is recalling Acetylcysteine 20% Ophthalmic solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    Acetylcysteine (PF) 20 % Opthalmic, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Magnesium Sulfate Injection Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling Magnesium Sulfate injections because sterility cannot be assured after a related product was found non-sterile.

    Product
    Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls WB-Tranexamic Acid Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling WB-Tranexamic acid products because sterility cannot be assured after a related product was found to be non-sterile.

    Product
    WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Naloxone Injectable Recalled Due to Lack of Assurance of Sterility

    Specialty Medicine Compounding Pharmacy is recalling Naloxone HCL 0.4mg/mL injectable because sterility cannot be assured after a related product was found to be non-sterile.

    Product
    NALOXONE HCL* 0.4MG/ML INJECTABLE, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Hydroxocobalamin Injectable Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling Hydroxocobalamin 10,000 mcg/mL injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    HYDROXOCOBALAMIN* 10,000 mcg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Triple Mix Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Triple Mix injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Vancomycin Ophthalmic Solution

    Specialty Medicine Compounding Pharmacy is recalling Vancomycin HCL 10 mg/mL Ophthalmic Solution because sterility cannot be assured. The product was distributed to healthcare providers and patients in Michigan.

    Product
    VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Calcium Chloride Injection Recalled Due to Sterility Assurance Concerns

    Specialty Medicine Compounding Pharmacy is recalling Calcium Chloride PF 500 mg/mL prefilled syringes because sterility cannot be assured after a related product was found non-sterile.

    Product
    Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling all unexpired sterile compounded human and veterinary products because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Glutathione PF Inhalation Solution

    Specialty Medicine Compounding Pharmacy is recalling Glutathione PF inhalation solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Tropicamide 1% Ophthalmic Solution Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Tropicamide 1% Ophthalmic Solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    TROPICAMIDE* 1% OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Testos Cypionate Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Testos Cypionate injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Naltrexone MDV Injectable

    Specialty Medicine Compounding Pharmacy is recalling Naltrexone MDV 1mg/mL injectable because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    NALTREXONE* MDV 1MG/ML INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Papaverine HCL Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Papaverine HCL injectable because sterility cannot be assured after another product was found non-sterile in the same environment.

    Product
    Papaverine HCL, 30 mg/mL injectable, also labeled as (10 mL) and (2 mL), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Methocarbamol Injectable Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Methocarbamol 100 mg/mL injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    METHOCARBAMOL (REPACK) 100 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Neomycin Sulfate Ophthalmic Solution Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Neomycin Sulfate ophthalmic solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state