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Showing 1421–1440 of 1571 results

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HCG Injection (Complete Pharmacy) – Non-sterility (2016)

Non-sterility - presence of bacteria confirmed by outside laboratory after day 14.

FDAApr 2, 2016Nationwide• Complete Pharmacy and Medical Solutions LLC

LGD-Xtreme Capsules (Invisiblu) – Unapproved Drug (2016)

Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033

Class IIModerate

FDAMar 31, 2016Nationwide• Invisiblu International LLC

Magnesium Sulfate Injection (Hospira) – Particulate Matter (2016)

Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.

Class IHigh

FDAMar 23, 2016Nationwide• Hospira Inc.

Magnesium Sulfate Injection (Hospira) – pH Specification Failure (2016)

Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.

FDAMar 23, 2016Nationwide• Hospira Inc.

Sodium Bicarbonate Injection (Hospira) – Insect Contamination (2016)

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

FDAMar 18, 2016Nationwide• Hospira Inc.

Quelicin Injection (Hospira) – Labeling Defect (2016)

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.

FDAMar 15, 2016Nationwide• Hospira Inc.

Normosol-M (Hospira) – Incorrect Expiration Date (2016)

Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".

FDAFeb 2, 2016Nationwide• Hospira Inc.

Human Chorionic Gonadotropin (Complete Pharmacy) – Mold Contamination (2015)

Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.

FDADec 29, 2015FL• Complete Pharmacy and Medical Solutions LLC

APEXXX Tablets (Nuway) – Unapproved Supplement (2015)

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.

FDADec 23, 2015Nationwide• Nuway Distributors, LLC

Vitamin D3 Supplement (Glades Drugs) – Superpotent Drug (2015)

Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).

FDANov 6, 2015GA, NY• Glades Drugs Inc.

Amidate Etomidate Injection (Hospira) – impurity degradation (2015)

Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.

FDASep 29, 2015Nationwide• Hospira Inc.

Miracle Diet Capsules (One Minute Miracle) – undeclared ingredient (2015)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.

FDAAug 27, 2015Nationwide• The One Minute Miracle Inc

Miracle Rock 48 (The One Minute Miracle) – undeclared drug ingredient (2015)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.

FDAAug 27, 2015Nationwide• The One Minute Miracle Inc

Lidocaine HCl Injection (Hospira) – particulate matter contamination (2015)

Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.

Class IIModerate

FDAAug 25, 2015Nationwide• Hospira, Inc.

Akttive Fat Burner Gold (Life and More) – undeclared ingredients (2015)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.

FDAJul 13, 2015Nationwide• Life and More LLC

Zero Xtreme Fat Burner (Xtreme Z) – undeclared ingredients (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

FDAJul 2, 2015Nationwide• XTREME Z DISTRIBUTORS INC

Ambisome 285 mg/250 mL (Franck's Lab) – sterility concern (2014)

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Class IIModerate

FDAMay 15, 2014FL• Franck's Lab Inc dba Trinity Care Solutions

Cefazolin 1 gm/100 mL (Franck's Lab) – sterility concern (2014)

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Class IIModerate

FDAMay 15, 2014FL• Franck's Lab Inc dba Trinity Care Solutions

Pfizerpen Penicillin G (Franck's Lab) – sterility concern (2014)

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Class IIModerate

FDAMay 15, 2014FL• Franck's Lab Inc dba Trinity Care Solutions

Desferal 2.5 gm/14 mL (Franck's Lab) – sterility concern (2014)

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Class IIModerate

FDAMay 15, 2014FL• Franck's Lab Inc dba Trinity Care Solutions

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