Category
Drug and pharmaceutical recalls
17707 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-DrugTeligent Pharma, Inc.Class IIEconazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.
Correct Labeled Product Mispack
- 2021-08-25FDA-DrugDr. Reddy's Laboratories, Inc.Class IITizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.
Failed Tablet/Capsule Specification: Some tablets are shaved
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIAdenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IILeucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IILeucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIOctreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIOctreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIMethylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIAlprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIMetoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIAdenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IINorepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIEpoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IILeucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIOctreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIVecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIIdarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIAmikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIHaloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454.
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIMethylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugTeva Pharmaceuticals USAClass IIDAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13
Lack of Assurance of Sterility
- 2021-08-25FDA-DrugSpirit PharmaceuticalsClass IIAcetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10
cGMP deviations: Discolored acetaminophen
- 2021-08-25FDA-DrugDuPont Nutrition USA, IncClass IIIAvicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
Out of specification results for conductivity.
- 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.
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