Drug and pharmaceutical recalls
17628 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2015-12-09FDA-DrugWestern DrugClass IIButor/Nal/Hydro Nasal Susp, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Lack of Assurance of Sterility
- 2015-12-09FDA-DrugWestern DrugClass IIBoric Acid 1% Ear Drop, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Lack of Assurance of Sterility
- 2015-12-09FDA-DrugWestern DrugClass IIBladder Mixture Prep, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Lack of Assurance of Sterility
- 2015-12-09FDA-DrugWestern DrugClass IIB-12 1000/B6 1000 mcg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Lack of Assurance of Sterility
- 2015-12-09FDA-DrugWestern DrugClass IIAMP50/B121MG Complex Mix/ML Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Lack of Assurance of Sterility
- 2015-12-09FDA-DrugWestern DrugClass IIAce-Promazine 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Lack of Assurance of Sterility
- 2015-12-09FDA-DrugWestern DrugClass IIProstin Injection 10 mcg/mL, 25 mcg/mL, 50 mcg/mL, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
Lack of Assurance of Sterility
- 2015-12-09FDA-DrugGeritrex CorpClass IIPolyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- 2015-12-09FDA-DrugGeritrex CorpClass IIGRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 10550, NDC 54162-015-12
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- 2015-12-09FDA-DrugGeritrex CorpClass IICarbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- 2015-12-09FDA-DrugGeritrex CorpClass IICarbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- 2015-12-09FDA-DrugNephron Pharmaceuticals Corp.Class IIAsthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-01
Discoloration
- 2015-12-09FDA-DrugNephron Pharmaceuticals Corp.Class IIAsthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron pharmaceuticals corporation, Orlando, FL --- NDC 0487-2784-10
Discoloration
- 2015-12-02FDA-DrugQualgenClass IITestosterone USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 25 mg (NDC 69761-125-01), 37.5 mg (NDC 69761-137-01), 50 mg (NDC 69761-150-01), 87.5 mg (NDC: 69761-187-01), 100 mg (NDC 69761-110-01), 200 mg (NDC 69761-120-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-12-02FDA-DrugQualgenClass IIEstradiol USP 99.5%, .5% Stearic Acid NF Pellets, 3 mL, one-count vials, 6 mg (NDC 69761-006-01),10 mg (NDC 69761-010-01),12.5 mg (NDC 69761-012-01), 15 mg (NDC 69761-015-01),18 mg (NDC 69761-018-01),20 mg (NDC 69761-020-01), 22 mg (NDC 69761-022-01), 25 mg (NDC 69761-025-01), Rx only, Compounded by Qualgen, Edmond, Oklahoma 73013
Lack of Assurance of Sterility: The firm is recalling all sterile preparations within expiry due to deficient practices which may have an impact on sterility assurance.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IITRIMIX SPECIAL (30 mg-1 mg-10 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IITRIMIX #4 (27 mg-1.5 mg-50 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IITRIMIX #3 (24 mg-1 mg-20 mcg/mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IITRIMIX #2 (24 mg-0.8 mg-20 mcg /mL) Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IITRIMIX #1 Injection, 4.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IITestosterone CYP/ENAN/PROP Injection in Cottonseed Oil, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IITestosterone CYP/ENAN/PROP Injection, 66.6 mg/66.6. mg/66.6 mg/mL, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IITestosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IITestosterone Cypionate 200 mcg/mL in Sesame Oil Injection, packaged a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IITestosterone Cypionate 50 mg/mL Injection, 1 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IIsermorelin 1000 mcg/mL / LIDO 0.2% Injection, 6 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IISermorelin 1000 mcg/mL SUB-Q* Injection, packaged in a) 3 mL, b) 6mL, c) 7.5ml, d) 9 mL or e) 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IISermorelin 9 mg/10 mL SUB-Q* Injection, packaged in a) 3 mL, b) 5 mL, c) 6 mL, or d) 9 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IIQUAD MIX (30 mg-1 mg-20 mcg-0.16 mg / mL) Injection, 5.2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
- 2015-11-25FDA-DrugKalman Health & Wellness, Inc. dba Essential Wellness PharmaClass IIProgesterone 100 mg/mL Ethyl Oleate Injection, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
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