Category
Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-08-25FDA-DrugHigh Performance Formulas, L.L.C. (HPF, L.L.C.)Class IICholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4
Marketed Without an Approved NDA/ANDA
- 2021-08-25FDA-DrugNovel Laboratories, Inc. d.b.a LUPINClass IIGaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19
Failed Stability Specification; Out of specification for Osmolarity
- 2021-08-25FDA-DrugNoven Pharmaceuticals IncClass IICombipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
Failed Stability Specifications; out of specification for shear.
- 2021-08-25FDA-DrugNoven Pharmaceuticals IncClass IICombipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
Failed Stability Specifications; out of specification for shear.
- 2021-08-18FDA-DrugPAI Holdings, LLC. dba Pharmaceutical Associates IncClass IIEthosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- 2021-08-18FDA-DrugPAI Holdings, LLC. dba Pharmaceutical Associates IncClass IICimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- 2021-08-18FDA-DrugPAI Holdings, LLC. dba Pharmaceutical Associates IncClass IINystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- 2021-08-18FDA-DrugEli Lilly & CompanyClass IIZyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
- 2021-08-18FDA-DrugAurobindo Pharma USA Inc.Class IISulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05
Presence of Foreign Substance- Potential of metal contamination.
- 2021-08-18FDA-DrugPeople's Custom Rx and Clinical Care, LLCClass IC-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Compounded, Rx only, People's Custom Rx, 785 E Brookhaven Cir, Memphis, TN 38117
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IHYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML, b) 2MG-35MG/ML, c) 25MG-15MG/ML, d) 6MG-1.5MG/ML, e) 3MG-3MG/ML, f) 5MG-15MG/ML, g)12MG-8MG/ML, h)2MG-2MG/ML, i) 30MG-30MG/ML, j) 8MG-20MG/ML, k) 20MG-10MG/ML, l)50MG-3.5MG/ML, m) 10MG-30MG/ML, n)15MG-1.6MG/ML, o) 20MG-30MG/ML, p)15MG-6MG/ML, q)15MG-27MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IHYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IMORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class ISUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IMORPHINE-BUPIVACAINE-KETAMINE PF INJECTABLE 21 mL syringe in two strengths: a) 5MG-25MG-5MG/ML, b) 1MG-2MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IMORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syringe, Rx only, Med Shop 470 E. Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IHYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in various strengths, a)10MG-20MG-100MCG/ML, b) 20MG-10MG-450MCG/ML, c) 13.3MG-3MG-3000MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IMORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syringes in various strengths: a) 20MG/ML-40MG/ML, b) 15MG-30MG/ML, c) 5MG/ML-20MG/ML, d) 2MG-30MG/ML, e) 20MG-5MG/ML, f) 15MG-5MG/ML, g) 5MG-2MG/ML, h) 5MG-11MG/ML, i) 20MG-6MG/ML, j) 10MG-10MG/ML, k) 6MG-4.8MG/ML, l) 30MG-10MG/ML, m) 5MG-4MG/ML, n) 10MG/ML-20MG/ML, o) 40MG-5MG/ML, p) 20MG-20MG/ML, q) 30MG-20MG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IHYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes in two strengths: a) 20MG-20MG-60MCG/ML INJECTABLE, b) 5MG-5MG-100MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IHYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in various strengths: a) 2.5MG-1.25MG-0.5MCG/ML, b) 10MG-5MG-10MCG/ML, c) 2MG-1MG-10MCG/ML, d) 10MG-5MG-10MCG/ML, e) 15MG-5MG-2000MCG/ML, f) 8MG-10MG-400MCG/ML, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IFENTANYL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 575MCG-18MG-6000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IFENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IBUPIVACAINE HCL-LIORESAL PF INJECTABLE 7.5MG-1625MCG/ML, 41 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugMed Shop Total Care Inc.Class IBUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx only, Med Shop Total Care 470 East Loop 281 Longview, TX 75605
Non-Sterility
- 2021-08-18FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIVenlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01
Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
- 2021-08-11FDA-DrugQikmoov LLCClass IVy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.com.
Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.
- 2021-08-11FDA-DrugBayCare Integrated Service Center, LLC /dba BayCare Central PharmacyClass IISuccinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837
Lack of sterility assurance
- 2021-08-11FDA-DrugPfizer Inc.Class IIChantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
- 2021-08-11FDA-DrugPfizer Inc.Class IIChantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
- 2021-08-11FDA-DrugPfizer Inc.Class IIChantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
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