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
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Prescription Drugs
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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
Failed impurities/degradation specifications
Class I - Dangerous
cGMP deviations
Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.
Morton Grove Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 11673-105-26
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-946-16
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed By Perrigo, Allegan, MI 49010. NDC: 0113-8959-26
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0971-26
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01
RISING PHARMACEUTICALS
Class I - Dangerous
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204. NDC: 37808-759-26
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 0113-0020-26
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-818-26
Perrigo Company PLC
Class I - Dangerous
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.