Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Class I - Dangerous
Lack of Assurance of Sterility
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.
Golden State Medical Supply
Class I - Dangerous
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Class I - Dangerous
Lack of Assurance of Sterility
Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Class I - Dangerous
Lack of Assurance of Sterility
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Class I - Dangerous
Lack of Assurance of Sterility
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
B. Braun Medical
Class I - Dangerous
Lack of sterility assurance: leaking bags
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Class I - Dangerous
Lack of Assurance of Sterility
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Class I - Dangerous
Lack of Assurance of Sterility
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
Walmart Stores
Class I - Dangerous
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Class I - Dangerous
Lack of Assurance of Sterility
Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Class I - Dangerous
Lack of Assurance of Sterility
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
The Harvard Drug Group
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Family Pharmacy of Statesville
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class I - Dangerous
Impurity failure at 0-time of the repackaged lot.
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06, c) 90 tablets per bottle, NDC: 68788-6381-09, Mfg: Par Pharmaceutical.
Preferred Pharmaceuticals
Class I - Dangerous
CGMP deviations
Class I - Dangerous
cGmp Deviations
Class I - Dangerous
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.