December 16, 2020DrugsFDA
Shilpa Medicare Limited recalls Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only, Rx Only, 8 mL Single Use Vial, Cytotoxic A
Hazard: CGMP Deviations
December 16, 2020DrugsFDA
Shilpa Medicare Limited recalls Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed
Hazard: CGMP Deviations
December 16, 2020DrugsFDA
Shilpa Medicare Limited recalls Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed
Hazard: CGMP Deviations
December 16, 2020DrugsFDA
Shilpa Medicare Limited recalls Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotox
Hazard: CGMP Deviations
December 16, 2020DrugsFDA
Shilpa Medicare Limited recalls Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotox
Hazard: CGMP Deviations
December 16, 2020DrugsFDA
Shilpa Medicare Limited recalls Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, S
Hazard: CGMP Deviations
December 16, 2020DrugsFDA
Fresenius Kabi USA, LLC recalls Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg / mL), 50 mL Single Dose Bottle, Rx only,
Hazard: Cross Contamination with other products: trace amounts of lidocaine
December 16, 2020DrugsFDA
Asiaticon, SA de CV recalls Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 FL OZ (400 mL), Distributed by: Safety-Med P
Hazard: Lack of CGMPs:
December 16, 2020DrugsFDA
Asiaticon, SA de CV recalls V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC 7 16053 70499 3; b) 16.9 fl oz (500 ml),
Hazard: Lack of CGMPs:
December 9, 2020DrugsFDA
Ascend Laboratories LLC recalls Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by Alkem Laboratories Ltd, Mumbai - 400 013,
Hazard: Failed Dissolution Specifications; Out of Specification (low) results were obtained.
December 9, 2020DrugsFDA
Torrent Pharma Inc recalls Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ
Hazard: Failed Dissolution Specifications
December 9, 2020DrugsFDA
Teligent Pharma, Inc. recalls Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-03
Hazard: Superpotent and Subpotent; low and high assay results
December 9, 2020DrugsFDA
MPM Medical LLC recalls REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesqu
Hazard: Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
December 9, 2020DrugsFDA
InvaTech Pharma Solutions, LLC recalls Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc.
Hazard: Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
December 9, 2020DrugsFDA
The Harvard Drug Group recalls Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontar
Hazard: Failed Dissolution Specifications: Out of specification for dissolution.
December 9, 2020DrugsFDA
US Pharmaceuticals Inc. recalls CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Dri
Hazard: Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
December 9, 2020DrugsFDA
Golden State Medical Supply Inc. recalls ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontari
Hazard: FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
December 9, 2020DrugsFDA
Lohxa LLC recalls Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 mL unit does cups (barcode 7016602715), pack
Hazard: Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
December 2, 2020DrugsFDA
Teligent Pharma, Inc. recalls Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08
Hazard: Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
December 2, 2020DrugsFDA
EYWA PHARMA INC recalls Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Manufactured by: VKT Pharma Private Limited Sr
Hazard: Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
December 2, 2020DrugsFDA
Heritage Pharmaceuticals Inc recalls Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc.
Hazard: Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
December 2, 2020DrugsFDA
Fusion Health and Vitality LLC recalls Immune Boost with natural strawberry flavor, 8,000 IU, Supports a Healthy and Balanced Immune System, 60 mL bottle, Manu
Hazard: Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
December 2, 2020DrugsFDA
Fresenius Kabi USA, LLC recalls DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only,
Hazard: Cross Contamination with Other Products: trace amounts of octreotide found during testing
December 2, 2020DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls clomiPRAMINE Hydrochloride Capsules USP, 50 mg, 30-count bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceutic
Hazard: Failed Tablet/Capsule Specification
December 2, 2020DrugsFDA
Sunstar Americas, Inc. recalls Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only, packaged in: a) 1 pint (473 mL) NDC 5237
Hazard: Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata.
December 2, 2020DrugsFDA
AA PRODUCTS INC recalls SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL OZ (500 mL) bottles,Biotecnologia, Educacion
Hazard: CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
November 25, 2020DrugsFDA
Apotex Corp. recalls Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 605
Hazard: Failed Dissolution Specifications: Out of specification for dissolution.
November 25, 2020DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, Preservative Free, For use as a sterile dil
Hazard: Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
November 25, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Pa
Hazard: Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
November 25, 2020DrugsFDA
Grato Holdings, Inc. recalls Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologicals, Inc. 469 W. Parkland Drive Sandy, UT 8
Hazard: Labeling: Product Contains Undeclared API; Incorrect formulation