Prescription Drugs Recalls

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Akorn

Class I - Dangerous

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

Mar 17, 2015 Prescription Drugs Nationwide View Details →

T4 66mcg - T3 10mcg SR Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

Health Innovations Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Feb 12, 2015 Prescription Drugs View Details →

Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Fallon Wellness Pharmacy, L.L.C.

Class I - Dangerous

Lack of assurance of sterility

Mar 17, 2015 Prescription Drugs View Details →

Cyanocobalamin 2000mcg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

Health Innovations Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Feb 12, 2015 Prescription Drugs View Details →

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetamide 9% and Sulfur 4.5% Wash, Net Wt. 16 oz (454 g), Daily Moisturizing Wash, 16 fl. oz. (473 mL), Manufactured for: BioComp Pharma Inc., San Antonio, TX 78230, NDC 44523-0609-23

Mission Pharmacal

Class I - Dangerous

Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.

Apr 30, 2015 Prescription Drugs Nationwide View Details →

Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Fallon Wellness Pharmacy, L.L.C.

Class I - Dangerous

Lack of assurance of sterility

Mar 17, 2015 Prescription Drugs View Details →

Ortho-Cept (0.15 mg desogestrel and 0.03 mg ethinyl estradiol) tablets, 28- count blister (21 active tablets and 7 placebo tablets)/ 6 blister packs per carton. Rx only, Jointly Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674 and NV Organon, Oss, The Netherlands, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560, New Jersey, NDC 50458-0196-15.

Janssen Pharmaceuticals

Class I - Dangerous

Subpotent Drug

Apr 29, 2015 Prescription Drugs Nationwide View Details →

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Akorn

Class I - Dangerous

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

Mar 17, 2015 Prescription Drugs Nationwide View Details →

Olanzapine, Orally Disintegrating Tablets, 10 mg, a) 30-count bottle (NDC 60505-3276-03), b) 100-count blister (NDC 60505-3276-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

Apotex

Class I - Dangerous

Subpotent drug

Apr 7, 2015 Prescription Drugs Nationwide View Details →

Methenamine/Phenyl Salicylate Capsule, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

Health Innovations Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Feb 12, 2015 Prescription Drugs View Details →

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Akorn

Class I - Dangerous

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

Mar 17, 2015 Prescription Drugs Nationwide View Details →

Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.

Cipla Limited

Class I - Dangerous

Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.

Apr 24, 2015 Prescription Drugs Nationwide View Details →

MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.

Hospira

Class I - Dangerous

Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.

Mar 6, 2015 Prescription Drugs Nationwide View Details →

17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

Health Innovations Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Feb 12, 2015 Prescription Drugs View Details →

Boric Acid Vaginal Capsules, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

Health Innovations Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Feb 12, 2015 Prescription Drugs View Details →

Testosterone 100 mg/1 mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

Health Innovations Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Feb 12, 2015 Prescription Drugs View Details →

Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9

Apotex

Class I - Dangerous

Subpotent drug

Apr 7, 2015 Prescription Drugs Nationwide View Details →

HCG 1000 Units/mL Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

Health Innovations Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Feb 12, 2015 Prescription Drugs View Details →

Levodopa 250 mg NSR Capsules,Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155

Health Innovations Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Feb 12, 2015 Prescription Drugs View Details →

Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sunscreen Broad Spectrum SPF 25, Net Wt. 3 oz (85 g), Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Net Wt. 16 oz (454 g), Manufactured for: BioComp Pharma Inc., San Antonio TX, 78230, NDC 44523-616-23

Mission Pharmacal

Class I - Dangerous

Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.

Apr 30, 2015 Prescription Drugs Nationwide View Details →