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.
- 2020-03-18FDA-DrugRedline Pharmacy SolutionsClass IIMorphine Sulfate (MITIGO), 5 mg/mL intrathecal, 40 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Lack Of Processing Controls
- 2020-03-18FDA-DrugRedline Pharmacy SolutionsClass IIVancomycin 900MG in 100ML 0.9% NACL Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Lack Of Processing Controls
- 2020-03-18FDA-DrugRedline Pharmacy SolutionsClass IIErtapenem in 100ML 0.9% NACL 1GM Injectable, Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Lack Of Processing Controls
- 2020-03-18FDA-DrugRedline Pharmacy SolutionsClass IIDaptomycin, 500MG in 0.9% NACL 100ML Injectable Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Lack Of Processing Controls
- 2020-03-18FDA-DrugRedline Pharmacy SolutionsClass IIMorphine Sulfate, 20 mg/mL intrathecal, 20 mL per syringe. Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Lack Of Processing Controls
- 2020-03-18FDA-DrugRedline Pharmacy SolutionsClass IIAcetylcysteine Ophthalmic 10% Solution, 5 mL per dropper bottle (10ML). Redline Specialty Pharmacy, 2415 Osborne Drive E, #100 Hastings, NE 68901
Lack Of Processing Controls
- 2020-03-18FDA-DrugH J Harkins Company Inc dba Pharma PacClass IIAcetaminophen 500 mg tablet packaged in a) 30-count bottles ( NDC 52959-0002-30), b) 42-count bottles (NDC 52959-0002-42), c) 45-count bottles (NDC 52959-0002-45) and e) 50-count bottles (NDC 52959-0002-50) Repack: H.J. Harkins Co., Inc. Grover Beach, CA 93433
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle
- 2020-03-18FDA-DrugPrecision Dose Inc.Class IIRanitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
- 2020-03-18FDA-DrugAmerican Health PackagingClass IIRanitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
- 2020-03-18FDA-DrugThe Harvard Drug GroupClass IIIQuetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6804-61
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- 2020-03-18FDA-DrugThe Harvard Drug GroupClass IIIQuetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6803-61
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- 2020-03-18FDA-DrugThe Harvard Drug GroupClass IIIQuetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6802-61
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- 2020-03-18FDA-DrugThe Harvard Drug GroupClass IIIQuetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6801-61
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- 2020-03-18FDA-DrugMayne Pharma IncClass IICarbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01
Product Mix-Up: A foreign tablet was found in bottle.
- 2020-03-18FDA-DrugSunstar Guangzhou Ltd.Class IISunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01
cGMP Deviation
- 2020-03-11FDA-DrugPfizer Inc.Class IIElelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01
Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IIZinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0224-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IICholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0251-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IICholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0210-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IITriamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IITriamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IITriamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0625-1
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IITriamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC # 71283-0633-1
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IITriamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0635-2
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IITriamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL [10ML] 40MG/5MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0632-1
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IITestosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0531-2
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IITestosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE, For IM Use, 1 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-2
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IITestosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-1
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IISuper MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0234-3
Lack of Assurance of Sterility
- 2020-03-11FDA-DrugFusion IV Pharmaceuticals, Inc. dba Axia PharmaceuticalClass IISelenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0227-3
Lack of Assurance of Sterility
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