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Showing 1161–1180 of 3363 results

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Testosterone Topical Solution (InvaGen) – Defective Container (2019)

Defective Container; actuator may improperly function and affect dose delivery.

Class IIILow

FDAJun 12, 2019Nationwide• InvaGen Pharmaceuticals, Inc.

Food Starch (Tate & Lyle) – Potential Wire Contamination (2019)

Product may contain small pieces of the wire due to a screen failure.

Class IIILow

FDAJun 10, 2019IN• Tate & Lyle Ingredients Americas, LLC

Myorisan Capsules (Akorn) – Labeling Error (2019)

Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.

Class IIILow

FDAJun 7, 2019Nationwide• Akorn Inc

Performance Mushrooms (Laird Superfood) – incorrect iron labeling (2019)

The product is incorrectly labeled with 14 mg of Iron and 78% DV when the actual amount is 14 mcg of Iron and 0% DV.

Class IIILow

FDAMay 24, 2019Nationwide• LAIRD SUPERFOOD INC

Ondansetron Injection (Fresenius Kabi) – impurity specifications (2019)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAMay 22, 2019Nationwide• Fresenius Kabi USA, LLC

Blue Plate Light Mayonnaise (Reily) – Yeast Gas Formation (2019)

Yeast presence that resulted in gas formation causing bottles to bloat and release mayonnaise.

Class IIILow

FDAMay 20, 2019AL, AR, CA +11 more• Reily Foods Co., Inc

Blue Plate Olive Oil Mayonnaise (Reily) – Yeast Gas Formation (2019)

Yeast presence that resulted in gas formation causing bottles to bloat and release mayonnaise.

Class IIILow

FDAMay 20, 2019AL, AR, CA +11 more• Reily Foods Co., Inc

Betamethasone Dipropionate Ointment (Teligent) – Impurity Specifications (2019)

Failed Impurities/Degradation Specifications

Class IIILow

FDAMay 20, 2019Nationwide• Teligent Pharma, Inc.

QUIK-CARE Hand Sanitizer (Ecolab) – Incorrect Alcohol (2019)

Undeclared Allergen

Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.

Class IIILow

FDAMay 10, 2019Nationwide• Ecolab Inc