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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA

ImprimisRx CA, Inc.

Class I - Dangerous

Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier

Jun 23, 2017 Prescription Drugs Nationwide View Details →

Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA

ImprimisRx CA, Inc.

Class I - Dangerous

Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier

Jun 23, 2017 Prescription Drugs Nationwide View Details →

Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10

Mckesson Packaging Services

Class I - Dangerous

Failed moisture limits: Out of specification for moisture content.

Aug 28, 2017 Prescription Drugs View Details →

Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01

Tris Pharma

Class I - Dangerous

Defective container: Oral solution leaking from container.

Jun 15, 2017 Prescription Drugs Nationwide View Details →

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054, NDC 60432-065-00.

Morton Grove Pharmaceuticals

Class I - Dangerous

Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.

Aug 10, 2017 Prescription Drugs Nationwide View Details →

Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00

Amphastar Pharmaceuticals

Class I - Dangerous

Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.

Aug 15, 2017 Prescription Drugs View Details →

Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150. NDC: 0536-1001-85

The Harvard Drug Group

Class I - Dangerous

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Aug 2, 2017 Other Drugs Nationwide View Details →

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 →

Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85

The Harvard Drug Group

Class I - Dangerous

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Aug 2, 2017 Other Drugs Nationwide View Details →

Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47

The Harvard Drug Group

Class I - Dangerous

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Aug 2, 2017 Other 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 →

Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09

The Harvard Drug Group

Class I - Dangerous

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Aug 2, 2017 Other Drugs Nationwide View Details →

Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, ?Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59

The Harvard Drug Group

Class I - Dangerous

Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination

Aug 2, 2017 Other 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 →

CaverFlo Natural Herbal Coffee, 25 g, supplied in boxes of 10 packets, manufacture for Caverflo Texas Trading -- UPC: 9555671709987

Brian P. Richardson

Class I - Dangerous

Marketed without an Approved NDA/ANDA; FDA analysis result found product to contain sildenafil, tadalafil and undeclared milk

May 25, 2017 Other Drugs 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 →