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Showing 1101–1120 of 14370 results

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RM-10 ULTRA Immune Support (Garden of Life) – Undeclared Soy (2023)

Undeclared Soy.

Class IIModerate

FDAOct 19, 2023Nationwide• Garden Of Life Llc

Midazolam Injection (Exela Pharma) – Particulate Problem (2023)

Presence of Particulate Matter: Silicone

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

ELCYS Injection (Exela Pharma) – Particulate Contamination (2023)

Presence of Particulate Matter: Silicone

Class IHigh

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

Sodium Bicarbonate Injection (Exela Pharma) – Particulate Issue (2023)

Presence of Particulate Matter: Silicone

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

Sucralfate Oral Suspension (VistaPharm) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

FDAOct 18, 2023Nationwide• VistaPharm LLC

Aminocaproic Acid Solution (VistaPharm) – High Ethylene Glycol (2023)

Failed Excipient Specifications: high content of ethylene glycol (EG)

FDAOct 17, 2023Nationwide• VistaPharm LLC

Synthroid Levothyroxine Tablets (AbbVie) – Incorrect Barcode (2023)

Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is scanned as 200mcg unit dose.

FDAOct 17, 2023IN, OR• AbbVie Inc.

The Rock Performance Capsules (Noah's Wholesale) – Unauthorized Sildenafil (2023)

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenafil an ingredient found in an FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

FDAOct 16, 2023FL• Noah's Wholesale LLC

Montelukast Sodium Tablets (Dr. Reddy's) – Foreign Tablet Contamination (2023)

Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.

Class IIModerate

FDAOct 13, 2023Nationwide• Dr. Reddy's Laboratories, Inc.

JayRobb Egg White Protein Powder (Select Custom) – Foreign Plastic (2023)

foreign material - plastic

Class IIModerate

FDAOct 13, 2023Nationwide• Select Custom Solutions, LLC

Bupropion Hydrochloride Tablets (Sun Pharma) – Dissolution Failure (2023)

Failed Dissolution Specifications

FDAOct 4, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Vancomycin HCI IV Bag (Denver Solutions) – Labeling Issue (2023)

Labeling: Not Elsewhere Classified

FDAOct 4, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Vancomycin HCI IV Bag (Denver Solutions) – Labeling Issue (2023)

Labeling: Not Elsewhere Classified

FDAOct 4, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Oxytocin IV Bag (Denver Solutions) – Labeling Issue (2023)

Labeling: Not Elsewhere Classified

FDAOct 4, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Epinephrine-Lidocaine Intraocular (Imprimis) – Subpotent Medication (2023)

Subpotent: Failing Test Results for Epinephrine

FDAOct 3, 2023Nationwide• Imprimis NJOF, LLC

Lidocaine Ophthalmic Solution (Pine) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Calcium Gluconate Irrigation Solution (Pine) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Lidocaine-Oxymetazoline Solution (Pine) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Foscarnet Sodium Injection (Pine) – Sterility Concern (2023)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 2, 2023Nationwide• Pine Pharmaceuticals, LLC

Lidocaine HCl Injection (Pfizer) – glass particulate matter (2023)

Presence of Particulate Matter: identified as glass.

FDAOct 2, 2023Nationwide• Pfizer Inc.

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