August 25, 2021DrugsFDA
Teva Pharmaceuticals USA recalls DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicine
Hazard: Lack of Assurance of Sterility
August 25, 2021DrugsFDA
Spirit Pharmaceuticals recalls Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville
Hazard: cGMP deviations: Discolored acetaminophen
August 25, 2021DrugsFDA
DuPont Nutrition USA, Inc recalls Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition U
Hazard: Out of specification results for conductivity.
August 25, 2021DrugsFDA
High Performance Formulas, L.L.C. (HPF, L.L.C.) recalls Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formu
Hazard: Marketed Without an Approved NDA/ANDA
August 25, 2021DrugsFDA
Novel Laboratories, Inc. d.b.a LUPIN recalls GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratori
Hazard: Failed Stability Specification; Out of specification for Osmolarity
August 25, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Sy
Hazard: Failed Stability Specifications; out of specification for shear.
August 25, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2
Hazard: Failed Stability Specifications; out of specification for shear.
August 18, 2021DrugsFDA
PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalls Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC
Hazard: Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
August 18, 2021DrugsFDA
PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalls Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenvill
Hazard: Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
August 18, 2021DrugsFDA
PAI Holdings, LLC. dba Pharmaceutical Associates Inc recalls Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL)
Hazard: Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
August 18, 2021DrugsFDA
Eli Lilly & Company recalls Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indian
Hazard: cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
August 18, 2021DrugsFDA
Aurobindo Pharma USA Inc. recalls Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Auro
Hazard: Presence of Foreign Substance- Potential of metal contamination.
August 18, 2021DrugsFDA
People's Custom Rx and Clinical Care, LLC recalls C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Ca
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East L
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 Eas
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls MORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longv
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 2
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/M
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML IN
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls FENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 L
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls BUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281
Hazard: Non-Sterility
August 18, 2021DrugsFDA
Med Shop Total Care Inc. recalls BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Lo
Hazard: Non-Sterility
August 18, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKAL
Hazard: Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
August 11, 2021DrugsFDA
Qikmoov LLC recalls Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured
Hazard: Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.
August 11, 2021DrugsFDA
BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy recalls Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802
Hazard: Lack of sterility assurance