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Prescription Drugs

💊 Drugs • 12,141 recalls

Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6145-10

C. O. Truxton

Class I - Dangerous

Labeling: Label Mixup; potentially mislabeled

Apr 20, 2017 Prescription Drugs Nationwide View Details →

Phentermine Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940

PD-Rx Pharmaceuticals

Class I - Dangerous

Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .

Aug 11, 2017 Prescription Drugs Nationwide View Details →

Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10

C. O. Truxton

Class I - Dangerous

Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital 15 mg tablets actually contained 30 mg tablets

Apr 20, 2017 Prescription Drugs Nationwide View Details →

Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6160-10

C. O. Truxton

Class I - Dangerous

Labeling: Label Mixup; potentially mislabeled

Apr 20, 2017 Prescription Drugs Nationwide View Details →

Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10

C. O. Truxton

Class I - Dangerous

Labeling: Label Mixup; potentially mislabeled

Apr 20, 2017 Prescription Drugs Nationwide View Details →

Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6151-10

C. O. Truxton

Class I - Dangerous

Labeling: Label Mixup; potentially mislabeled

Apr 20, 2017 Prescription Drugs Nationwide View Details →

Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b) 1000 count bottles (NDC 0163-6152-10), Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031

C. O. Truxton

Class I - Dangerous

Labeling: Label Mixup; potentially mislabeled

Apr 20, 2017 Prescription Drugs Nationwide View Details →

Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30

Hetero USA

Class I - Dangerous

Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.

Jul 20, 2017 Prescription Drugs View Details →

0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-7983-09

ICU Medical

Class I - Dangerous

Presence of Particulate Matter; stainless steel

Jul 26, 2017 Prescription Drugs Nationwide View Details →

Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940

KVK-Tech

Class I - Dangerous

Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.

Aug 3, 2017 Prescription Drugs Nationwide View Details →

Mibelas 24 Fe (Norethindrone acetate and Ethinyl estradiol 1 mg/0.02 mg chewable and ferrous Fumarate 75 mg) Tablets, wallet of 28 tablets (NDC 68180-911-11), Carton of 3 wallets (NDC 68180-911-13), Rx Only, Manufactured by: Lupin Limited, India, Distributed by Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202

Lupin Limited (Unit 1)

Class I - Dangerous

Contraceptive Tablets Out of Sequence- First 4 pills of the packet are brown, instead of the last four pills and the expiry/lot was not printed on the package.

May 16, 2017 Prescription Drugs Nationwide View Details →

Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97012

Akorn

Class I - Dangerous

Crystallization with subpotent out of specification assay results for chlorhexidine.

Jul 12, 2017 Prescription Drugs Nationwide View Details →

Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01

Amgen

Class I - Dangerous

Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product vials.

Aug 4, 2017 Prescription Drugs View Details →

Biotech Underground Tri-Ton Hardcore Formula capsules, 90-count bottle, Distributed by: Dynamic Technical Formulations 12850 Hwy 9 Suite 600-441 Alpharetta, GA 30004

DYNAMIC TECHNICAL FORMULATIONS

Class I - Dangerous

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Product was tested by FDA and found to contain andarine and ostarine.

May 19, 2017 Prescription Drugs Nationwide View Details →

Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose cup (NDC 50383-720-15), b) 100-count tray (NDC 50383-720-19), Rx Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701.

Akorn

Class I - Dangerous

Crystallization with subpotent out of specification assay results for chlorhexidine.

Jul 12, 2017 Prescription Drugs Nationwide View Details →

Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlorhexidine Gluconate Oral Rinse. Manufactured by Halyard Health Inc., 5405 Windward Parkway, Alpharetta, GA 30004. Distributed by Halyard Sales, LLC Alpharetta, GA 30004. REF # 97014

Akorn

Class I - Dangerous

Crystallization with subpotent out of specification assay results for chlorhexidine.

Jul 12, 2017 Prescription Drugs Nationwide View Details →

GEC LX Laxoplex 60 capsules Dietary Supplement, 60 count bottle, Manufactured by GEC, McKinney, TX, 75070, UPC: 700580499842

Genetic Edge Compounds

Class I - Dangerous

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: FDA analysis found the product to tainted with undeclared anabolic steroids and steroid like substances.

May 5, 2017 Prescription Drugs Nationwide View Details →

D-ZINE Rapid Size and Strength capsules, 10mgs, 90 count bottle, Hardcore Formulations, UPC: 7 48252 86193 1

HARDCORE FORMULATIONS

Class I - Dangerous

Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.

Jul 5, 2017 Prescription Drugs Nationwide View Details →

Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12

AVKARE

Class I - Dangerous

Failed impurities/degradation specifications: Out of specification for a related compound C.

Jul 19, 2017 Prescription Drugs Nationwide View Details →

ULTRA-STEN Rapid Size and Strength capsules, 10 mgs, 90 count bottle, Hardcore Formulations UPC: 7 48252 68763 0

HARDCORE FORMULATIONS

Class I - Dangerous

Marketed Without An Approved NDA/ANDA: Product contains Methylstenbolone or Dymethazine.

Jul 5, 2017 Prescription Drugs Nationwide View Details →

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