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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 241–260 of 1,000 recalls

Class ITerminated

FENTANYL-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

Med Shop Total Care Inc.

Non-Sterility

October 5, 2020 · DrugView details →

Class ITerminated

Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #: 92317-144, UPC 8 50016 92317 2, NDC 70108-045-01); d) Barbie (Item #: 92318-144, UPC 8 50016 92318 9, NDC 70108-046-01); e) Trolls (Item #: 92322-144, UPC 8 50016 92322 6, NDC 70108-047-01); and f) Minions (Item #: 92319-144, UPC 8 50016 92319 6, NDC 70108-043-01); Distributed by Ashtel Studios Inc., Ontario, CA 91761

ASHTEL STUDIOS, INC.

Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches

October 1, 2020 · Drug

View details →

Class ITerminated

Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5

Wishgarden Herbs, Incorporated

Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.

September 25, 2020 · DrugView details →

Class ITerminated

Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Boulder, CO 80301. UPC 6 56490 64137 9

Wishgarden Herbs, Incorporated

Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.

September 25, 2020 · DrugView details →

Class ITerminated

Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulder, CO 80301. UPC 6-56490 24730 4

Wishgarden Herbs, Incorporated

Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.

September 25, 2020 · DrugView details →

Class ITerminated

NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01

Acella Pharmaceuticals, LLC

Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.

September 17, 2020 · DrugView details →

Class ITerminated

NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01

Acella Pharmaceuticals, LLC

Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.

September 17, 2020 · DrugView details →

Class ITerminated

M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code: 77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX 78516, NDC Code: 75432-001-02.

MEDEK LLC

Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.

September 9, 2020 · DrugView details →

Class ITerminated

Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, McLean, VA 22102, USA, Made in China.

CORGIOMED LLC

Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.

September 3, 2020 · DrugView details →

Class ITerminated

Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag stapled with cardboard labeling.

The Protein Shoppe

Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug fro which the safety and efficacy have not been established and therefore subject to recall.

September 1, 2020 · DrugView details →

Class ITerminated

Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg], 100-count bottles, Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3303-1

RLC Labs Inc.

Subpotent Drug: FDA analysis found product to be subpotent

August 25, 2020 · DrugView details →

Class ITerminated

Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 30-count bottles (NDC 64727-3305-4), b) 60-count bottles (NDC 64727-3305-5), c) 90-count bottles (NDC 64727-3305-6), and 100-count bottles (NDC 64727-3305-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3305-1

RLC Labs Inc.

Subpotent Drug: FDA analysis found product to be subpotent

August 25, 2020 · DrugView details →

Class ITerminated

WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 30-count bottles (NDC 64727-5550-4), b) 90-count bottles (NDC 64727-5550-6), c) 100-count bottles (NDC 64727-5550-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024

RLC Labs Inc.

Subpotent Drug: FDA analysis found product to be subpotent

August 25, 2020 · DrugView details →

Class ITerminated

Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 90-count bottles (NDC 64727-3299-6), b) 100-count bottles (NDC 64727-3299-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034

RLC Labs Inc.

Subpotent Drug: FDA analysis found product to be subpotent

August 25, 2020 · DrugView details →

Class ITerminated

Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levothyroxine (T4) 76 mcg], packaged in a) 30-count bottles (NDC 64727-3308-4) and b)100-count bottles (NDC 64727-3308-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024

RLC Labs Inc.

Subpotent Drug: FDA analysis found product to be subpotent

August 25, 2020 · DrugView details →

Class ITerminated

Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, Levothyroxine (T4) 28.5 mcg], packaged in a) 100-count bottles (NDC 64727-3302-1) and b) 1000-count bottles (NDC 64727-3302-2), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034

RLC Labs Inc.

Subpotent Drug: FDA analysis found product to be subpotent

August 25, 2020 · DrugView details →

Class ITerminated

Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural Products, www.maisonterre.net

Maison Terre, LLC

Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be contaminated with various microorganisms including Enterobacter cloacae, Cronobacter sakazakii, Cronobacter dublinensis, among others.

August 17, 2020 · DrugView details →

Class ITerminated

Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.

Mylan Institutional LLC

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

August 17, 2020 · DrugView details →

Class ITerminated

Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.

Mylan Institutional LLC

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

August 17, 2020 · DrugView details →

Class ITerminated

SkinGuard 24 All-Day Hand Sanitizer 8 oz. bottle with foam pump, Dist by: SG24 LLC, Bolingbroke, GA 31004 UPC 793573147125

SG24 LLC

Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug

August 14, 2020 · DrugView details →

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