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Prescription Drugs

💊 Drugs • 12,141 recalls

Risedronate Sodium Delayed-release Tablets, 35 mg, Once-a-Week, 1 tablet per blister (NDC 0093-5509-19), packaged in 4 blisters per carton (NDC 0093-5509-44), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Dissolution Specifications

Dec 1, 2016 Prescription Drugs Nationwide View Details →

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840

L. Perrigo Company

Class I - Dangerous

Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap

Dec 28, 2016 Prescription Drugs Nationwide View Details →

Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10-count Carton of 1.0 g sample packets), NDC 69646-704-38 (10 ct. Carton of 1gm samples) / NDC 69646-704-01 (Individual 1gm Samples within Carton), Rx Only, Novum Pharma LLC, Chicago, IL 60654

Novum Pharma

Class I - Dangerous

Subpotent Drug: Out of specification result for pramoxine hydrochloride

Dec 7, 2016 Prescription Drugs Nationwide View Details →

Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.

Sandoz

Class I - Dangerous

Subpotent Drug: out of specification results for assay test.

Dec 13, 2016 Prescription Drugs Nationwide View Details →

HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459

Town and Country Compounding and Consultation Services

Class I - Dangerous

Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).

Oct 18, 2016 Prescription Drugs Nationwide View Details →

Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.

Noven Pharmaceuticals

Class I - Dangerous

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.

Aug 22, 2016 Prescription Drugs Nationwide View Details →

HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20

Pharm D Solutions

Class I - Dangerous

Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct

Oct 12, 2016 Prescription Drugs View Details →

10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06

Baxter Healthcare

Class I - Dangerous

Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.

Dec 6, 2016 Prescription Drugs View Details →

Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.

Noven Pharmaceuticals

Class I - Dangerous

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.

Aug 22, 2016 Prescription Drugs Nationwide View Details →

Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04

Pharm D Solutions

Class I - Dangerous

Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct

Oct 12, 2016 Prescription Drugs View Details →

Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34

Pfizer

Class I - Dangerous

Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months

Sep 9, 2016 Prescription Drugs Nationwide View Details →

Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186, NDC 68968-5552-3

Noven Pharmaceuticals

Class I - Dangerous

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.

Aug 22, 2016 Prescription Drugs Nationwide View Details →

Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01

Apotex

Class I - Dangerous

CGMP Deviations

Dec 14, 2016 Prescription Drugs View Details →

Carnitine-L 250 mg/mL Injectable, 30 mL vials, Rx only, Compounded by Wells Pharmacy, Ocala, FL

Wells Pharmacy Network

Class I - Dangerous

Lack of Assurance of Sterility

Sep 21, 2016 Prescription Drugs Nationwide View Details →

Ceftazidime, Lyophilized, Ophthalmic 2.25% Kit, Rx only, Compounded by Wells Pharmacy, Ocala , FL

Wells Pharmacy Network

Class I - Dangerous

Lack of Assurance of Sterility

Sep 21, 2016 Prescription Drugs Nationwide View Details →

Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01

Apotex

Class I - Dangerous

CGMP Deviations

Dec 14, 2016 Prescription Drugs View Details →

TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21

Vintage Pharmaceuticals LLC

Class I - Dangerous

Failed Stability Specifications

Dec 22, 2016 Prescription Drugs Nationwide View Details →

Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy

Tri-Coast Pharmacy

Class I - Dangerous

Lack of Assurance of Sterility

Nov 17, 2016 Prescription Drugs Nationwide View Details →

Virt-Select Prenatal/Postnatal Softgels, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-249-30

VIRTUS PHARMACEUTICALS OPCO II L

Class I - Dangerous

cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

Dec 12, 2016 Prescription Drugs Nationwide View Details →

Extra-Virt Plus DHA Prenatal/Postnatal Softgel, Prescription Multivitamin/Mineral Dietary Supplement with Fish-Based DHA , packaged in 30-count bottle, Rx only, Made in Canada, NDC 76439-251-30

VIRTUS PHARMACEUTICALS OPCO II L

Class I - Dangerous

cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.

Dec 12, 2016 Prescription Drugs Nationwide View Details →

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