FDA Recall
Terminated
Historical recordClass II
Cyclo/PE/Trop PF (1%/2.5%/1%), 3 mL dropper bottle, For topical ophthalmic use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3049-03
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Brompheniramine Maleate (10 mg/mL), 10 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3019-07
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bi-Mix (Papaverine 30 mg/mL, Phentolamine 1 mg/mL), 5 mL Multi-Dose Vial, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3254-05
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Betamethasone SP PF (12 mg/mL), 2 mL Single Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3016-02
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Betamethasone SP, 2 mL (6 mg/mL),10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3240-07
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Betamethasone Combo PF 2 mL (6 mg/mL) 10 mL Multi-Dose Vial, For IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-02
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Betamethasone Combo 10 mL (7 mg/mL), 10 mL Multi-Dose Vial,for IM & Regional Injection, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3018-10
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032.
by US Compounding Inc
- Reason
- Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for impurities.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
by Par Pharmaceutical Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification for impurities.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93.
by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Reason
- Presence of Particulate Matter.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.
by Akorn, Inc.
- Reason
- Failed Impurity/Degradation Specifications: Out of Specifications result obtained for a known impurity.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone 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.
by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Reason
- 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.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone 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.
by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Reason
- 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.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate 200 mcg/mL in Corn Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Reason
- 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.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Reason
- 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.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Progesterone 100 mg/mL IM* Injection in Sesame Oil, 10 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Reason
- 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.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MIC Injection, 30 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Reason
- 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.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DUAL TEST CYP/ENA 1:1 200 mg/mL Injection, packaged in a) 5 mL and b) 100 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
by Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
- Reason
- 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.
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
B12 Injection 12.5/12.5MG, 3mL, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
by Downing Labs, LLC
- Reason
- Lack of Assurance of Sterility
- Published
- November 25, 2015
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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