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

26–50 of 51

  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls Methylcobalamin Injectable Due to Sterility Concerns

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

    Product
    METHYLCOBALAMIN * 10 mg/mL INJECTABLE, METHYLCOBALAMIN * UD/PF 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 1000 mcg/mL INJECTABLE, METHYLCOBALAMIN* 25 mg/mL INJECTABLE, METHYLCOBALAMIN* 5000 mcg/mL INJECTABLE, METHYLCOBALAMIN* PF 1000 mcg/mL PREF SYRINGE, Rx only, Specialty Medicine Co
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Sodium tetradecyl sulfate recalled due to lack of sterility assurance

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

    Product
    Sodium tetradecyl SO4, 3% 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 EDETATE DISODIUM Ophthalmic Solution

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

    Product
    EDETATE DISODIUM* (0.05M) 1.7% OPHTH SOL, 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 Ceftazidime Ophthalmic Solution

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

    Product
    Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Dexamethasone Solution Recalled Due to Lack of Sterility Assurance

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

    Product
    DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    FDA Recalls Aluminum Potassium Sulfate Sterile Powder Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Aluminum Potassium Sulfate Sterile powder because sterility cannot be assured after a related product was found non-sterile.

    Product
    Aluminum Potassium Sulfate Sterile powder, 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 Multitrace-4 Pediatric Injection

    Specialty Medicine Compounding Pharmacy is recalling Multitrace-4 pediatric injections because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    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
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Specialty Medicine Compounding Pharmacy Recalls VIGAMOX Syringes Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling 204 doses of VIGAMOX (moxifloxacin) syringes because sterility cannot be assured after another product was found non-sterile.

    Product
    VIGAMOX (moxifloxacin)* IN BSS (0.15 %) 0.75 mg/0.5 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 Injectable Drug Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Papav/Phentol/PG E1 injectable products because sterility cannot be assured after a related product was found non-sterile.

    Product
    Papav/Phentol/PG E1, 30 mg/1 mg/20 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

    Lidocaine/Sodium Chloride Injectable Recalled Due to Sterility Concerns

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

    Product
    LIDOCAINE/SODIUM CHL* 0.4 %/18 % 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 Hydroxide Solution Recalled Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Sodium Hydroxide 10% Solution because sterility cannot be assured after a related product was found non-sterile.

    Product
    SODIUM HYDROXIDE (BAC.STATIC) 10% 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 Quad Mix Injectable Due to Sterility Concerns

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

    Product
    QUAD MIX* IN NACL (1.8/0.2/0.02)mg/18 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 Hydroxocobalamin/Thiamine Injectable

    Specialty Medicine Compounding Pharmacy is recalling Hydroxocobalamin/Thiamine Injectable due to lack of assurance of sterility. The product was distributed to healthcare providers in Michigan.

    Product
    HYDROXOCOBALAMIN/THIAMINE* 1 mg/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

    Cyclopentolate HCL Ophthalmic Recall Due to Sterility Concerns

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

    Product
    CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Gatifloxacin Ophthalmic Drops Recalled for Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling repackaged Gatifloxacin ophthalmic drops because sterility cannot be assured due to shared compounding practices with a non-sterile product.

    Product
    Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • HighFDA (Drugs)··2014-01-22

    FDA Recalls Bevacizumab Due to Lack of Assurance of Sterility

    Specialty Medicine Compounding Pharmacy is recalling repackaged Bevacizumab because sterility cannot be assured. The recall affects 2,801 doses distributed in Michigan.

    Product
    Bevacizumab, (repackaged) in a) 0.11 mL and b) 0.06 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 Quad Mix Injectable Due to Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Quad Mix and Super Quad Mix injectables because sterility cannot be assured after a related product was found non-sterile.

    Product
    QUAD MIX* 0.05 mg/25 mg/2 mg/25 mcg/mL INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, QUAD MIX* 0.1 mg/30 mg/2 mg/50 mcg INJECTABLE, QUAD MIX* 0.1 mg/9 mg/1 mg/10 mcg/mL INJECTABLE, SUPER QUAD MIX* 0.1 mg/30 mg/2 mg/20 mcg INJECTABLE, (pavaperine HCl, phentolamine, pr
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Phenylephrine/Tropicamide Ophthalmic Solution Recalled for Sterility Concerns

    Specialty Medicine Compounding Pharmacy is recalling Phenylephrine/Tropicamide ophthalmic solution because sterility cannot be assured due to environmental contamination risks.

    Product
    Phenylephrine/Tropicamide 2.5 %/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

    Proparacaine HCl Ophthalmic Solution Recalled for Sterility Concerns

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

    Product
    Proparacaine HCl PF, 0.5% 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 Epinephrine Due to Sterility Concerns

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

    Product
    EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-01-22

    Polidocanol Injectable Recalled Due to Lack of Sterility Assurance

    Specialty Medicine Compounding Pharmacy is recalling Polidocanol 3% injectable because sterility cannot be assured after a related product was found non-sterile.

    Product
    Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
    Category
    Distribution
    1 state