💊

Prescription Drugs

💊 Drugs • 12,141 recalls

PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029.

SCA Pharmaceuticals

Class I - Dangerous

Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.

Apr 28, 2015 Prescription Drugs View Details →

Hyaluronidase (RM ONLY), Injectable Solution, 150 U/mL, 10ML vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Montana Compounding Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

May 15, 2015 Prescription Drugs View Details →

Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03

Baxter Healthcare

Class I - Dangerous

Subpotent Drug; out of specification results for heparin raw material

Jun 3, 2015 Prescription Drugs Nationwide View Details →

Alprostadil (PFE1), solution, 30 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Montana Compounding Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

May 15, 2015 Prescription Drugs View Details →

Nifedipine Extended-Release Tablets, USP, 90 mg, 100 Tablet Bottles, Rx Only. Manufactured for: Teva Pharmaceuticals USA Sailorsville, PA 13960. Manufactured in Canada By: Valeant Pharmaceuticals International, Inc. Steinbach, MB R5G 127 Canada. NDC: 0093-2059-01.

Valeant Pharmaceuticals North America

Class I - Dangerous

Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.

Apr 17, 2015 Prescription Drugs Nationwide View Details →

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/240) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Montana Compounding Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

May 15, 2015 Prescription Drugs View Details →

Alprostadil (PFE1), Solution, 10 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Montana Compounding Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

May 15, 2015 Prescription Drugs View Details →

Trimix (A;PH,PA) (N), injectable, 160 UG-1.2 mg-9.6/ mg/mL, 2 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT.

Montana Compounding Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

May 15, 2015 Prescription Drugs View Details →

MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointestinal Radiography; Oral or rectal use only; Rx only; 30 mL; Single-Unit Container; ; Mallinckrodt Inc., St. Louis, MO 63042. NDC 0019-4816-04

Mallinckrodt

Class I - Dangerous

Labeling: incorrect or missing lot number and/or expiration date

May 15, 2015 Prescription Drugs View Details →

Trimix (A;PH,PA) (N), injectable, 80 UG-0.6 mg-4.8 mg/mL, 1 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Montana Compounding Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

May 15, 2015 Prescription Drugs View Details →

Glutathione INHALATION (PF), NASAL solution, 100 mg/mL, 3 mL vial, Rx only, dispensed by Montana Compounding Pharmacy, Missoula, MT

Montana Compounding Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

May 15, 2015 Prescription Drugs View Details →

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 50383-0796-16

Akorn

Class I - Dangerous

Failed Impurities/Degradation Specifications

Apr 7, 2015 Prescription Drugs Nationwide View Details →

Avastin, solution, 1.25 mg/0.05mL, Injectable, Syringe, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Montana Compounding Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

May 15, 2015 Prescription Drugs View Details →

Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16

Akorn

Class I - Dangerous

Failed Impurities/Degradation Specifications

Apr 7, 2015 Prescription Drugs Nationwide View Details →

Trimix (PGE1;PHENT;PAP) (N), injectable, (100/10/297) 10UG, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Montana Compounding Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

May 15, 2015 Prescription Drugs View Details →

Alprostadil (PFE1), solution, 20 mcg/mL, injectable, 5 mL vial, Rx only, compounded by Montana Compounding Pharmacy, Missoula, MT

Montana Compounding Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection

May 15, 2015 Prescription Drugs View Details →

Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College Road West, Princeton, NJ 08540. NDC 66394-041-06

Sandoz

Class I - Dangerous

Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.

Apr 15, 2015 Prescription Drugs Nationwide View Details →

Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Dissolution Specifications: OOS result during stability testing

May 11, 2015 Prescription Drugs Nationwide View Details →

KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electrolytes and (9.8%) Dextrose; Sulfite-free], Rx Only. Manufactured by: FRESENIUS KABI Uppsala, Sweden. Packaged in 1) 1,540 mL Bags, NDC: 63323-712-15, and 2) 2,053 mL Bags, NDC: 63323-712-20.

Fresenius Kabi USA

Class I - Dangerous

Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids

Apr 28, 2015 Prescription Drugs Nationwide View Details →

Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.

Mylan Lab

Class I - Dangerous

Failed Dissolution Specifications: Low out of specification dissolution results.

May 20, 2015 Prescription Drugs Nationwide View Details →

← Back to All Drugs Recalls