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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 161–180 of 1,000 recalls

Class ITerminated

Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, packaged in a) (16.9oz) 500 mL (UPC 8 60003 31899 7, NDC: 73891-100-14); and b) (20oz) 591 mL (UPC 8 60003 65984 7 NDC: 73891-100-15) bottles, Prairie Wolf Distillery, Guthrie, Oklahoma

Prairie Wolf Spirits

Hand sanitizer packaged in bottles that resemble beverage containers.

June 21, 2021 · DrugView details →
Class ITerminated

Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71

Teva Pharmaceuticals USA

Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.

June 18, 2021 · Drug
View details →
Class ITerminated

PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006

Miracle 8989

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

May 18, 2021 · DrugView details →
Class ITerminated

maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), Distributed by: Maxx Inc, Los Angeles, CA 90028

Miracle 8989

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

May 18, 2021 · DrugView details →
Class ITerminated

PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006

Miracle 8989

Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.

May 18, 2021 · DrugView details →
Class ITerminated

DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distributed by S.E.N.D. LLC, Anthony, NM 88021, Imported by Dibar Labs, LLC, Sugar Land, TX 77479, Made in Mexico,77479, NDC 73009-0001-08 UPC 8 53090 00301 3.

DIBAR NUTRICIONAL S DE RL DE CV

Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.

May 11, 2021 · DrugView details →
Class ITerminated

C-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

People's Custom Rx and Clinical Care, LLC

Non-Sterility

May 11, 2021 · DrugView details →
Class ITerminated

Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0

Yamtun7

Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

May 11, 2021 · DrugView details →
Class ITerminated

0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.

PFIZER, INC

Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

May 3, 2021 · DrugView details →
Class ITerminated

1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose vial (NDC 0409-4279-16), packaged in 25 vials per tray (NDC 0409-4279-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.

PFIZER, INC

Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP

May 3, 2021 · DrugView details →
Class ITerminated

NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

Acella Pharmaceuticals, LLC

Subpotent Drug

April 29, 2021 · DrugView details →
Class ITerminated

NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 42192-329-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

Acella Pharmaceuticals, LLC

Subpotent Drug

April 29, 2021 · DrugView details →
Class ITerminated

NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-330-01

Acella Pharmaceuticals, LLC

Subpotent Drug

April 29, 2021 · DrugView details →
Class ITerminated

NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-331-01

Acella Pharmaceuticals, LLC

Subpotent Drug

April 29, 2021 · DrugView details →
Class ITerminated

NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

Acella Pharmaceuticals, LLC

Subpotent Drug

April 29, 2021 · DrugView details →
Class ITerminated

Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 814630 02423 3

Scentsational Soaps & Candles Inc

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

April 27, 2021 · DrugView details →
Class ITerminated

Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01332 5

Scentsational Soaps & Candles Inc

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

April 27, 2021 · DrugView details →
Class ITerminated

Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL),Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 18489 01333 2

Scentsational Soaps & Candles Inc

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

April 27, 2021 · DrugView details →
Class ITerminated

SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Black and White Collection; b) Photo Real Collection

Scentsational Soaps & Candles Inc

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

April 27, 2021 · DrugView details →
Class ITerminated

Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01331 8

Scentsational Soaps & Candles Inc

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

April 27, 2021 · DrugView details →
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