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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90

Novocol Pharmaceutical of Canada

Class I - Dangerous

Labeling: Label mix-up

Nov 20, 2020 Prescription Drugs Nationwide View Details →

Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.

Shilpa Medicare Limited

Class I - Dangerous

CGMP Deviations

Dec 8, 2020 Prescription Drugs Nationwide View Details →

Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72485-216-08.

Shilpa Medicare Limited

Class I - Dangerous

CGMP Deviations

Dec 8, 2020 Prescription Drugs Nationwide View Details →

Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, Vial NDC 72485-210-01, Carton NDC 72485-210-08.

Shilpa Medicare Limited

Class I - Dangerous

CGMP Deviations

Dec 8, 2020 Prescription Drugs Nationwide View Details →

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-671-05

Fresenius Kabi USA

Class I - Dangerous

Cross Contamination with other products: trace amounts of lidocaine

Nov 17, 2020 Prescription Drugs Nationwide View Details →

Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.

Shilpa Medicare Limited

Class I - Dangerous

CGMP Deviations

Dec 8, 2020 Prescription Drugs Nationwide View Details →

Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med Products, Inc. Burlington, WI 53105 Made in Mexico by Asiaticon S.A. de C.V. Conkal No. 62, Mexico, Ciudad de Mexico 14200, Mexico NDC: 75192-600-02 UPC 7 503019 005002

Asiaticon, SA de CV

Class I - Dangerous

Lack of CGMPs:

Aug 25, 2020 Other Drugs View Details →

Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462-01

Torrent Pharma

Class I - Dangerous

Failed Dissolution Specifications

Nov 25, 2020 Prescription Drugs Nationwide View Details →

ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30

Golden State Medical Supply

Class I - Dangerous

FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets

Nov 17, 2020 Prescription Drugs Nationwide View Details →

Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60

Teligent Pharma

Class I - Dangerous

Superpotent and Subpotent; low and high assay results

Nov 5, 2020 Prescription Drugs Nationwide View Details →

CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1

US Pharmaceuticals

Class I - Dangerous

Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.

Nov 19, 2020 Compounded Drugs View Details →

Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6512-04

The Harvard Drug Group

Class I - Dangerous

Failed Dissolution Specifications: Out of specification for dissolution.

Nov 18, 2020 Prescription Drugs Nationwide View Details →

Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013, INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC: 67877-614-15.

Ascend Laboratories

Class I - Dangerous

Failed Dissolution Specifications; Out of Specification (low) results were obtained.

Nov 24, 2020 Prescription Drugs View Details →

Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), packaged in 50-count unit dose cups per carton, Rx only, Distributed by: Lohxa, Worcester, MA 01608, NDC 70166-027-15

Lohxa

Class I - Dangerous

Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.

Oct 28, 2020 Prescription Drugs View Details →

Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30

InvaTech Pharma Solutions

Class I - Dangerous

Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.

Nov 11, 2020 Prescription Drugs Nationwide View Details →

REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesquite, TX 75149. NDC 66977-107-03

MPM Medical

Class I - Dangerous

Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.

Nov 17, 2020 Other Drugs Nationwide View Details →

Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-010-59

Teligent Pharma

Class I - Dangerous

Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.

Nov 3, 2020 Prescription Drugs Nationwide View Details →

clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD NDC 59746-711-30

Jubilant Cadista Pharmaceuticals

Class I - Dangerous

Failed Tablet/Capsule Specification

Nov 6, 2020 Prescription Drugs Nationwide View Details →

DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05

Fresenius Kabi USA

Class I - Dangerous

Cross Contamination with Other Products: trace amounts of octreotide found during testing

Nov 17, 2020 Prescription Drugs Nationwide View Details →

SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion y Genetica, S.A. de C.V. Av. Quetra, UPC 9 780201 378624 .

AA PRODUCTS

Class I - Dangerous

CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.

Sep 24, 2020 Other Drugs View Details →