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Showing 4161–4180 of 14370 results

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Sesame Seed Bagel (San Francisco Street Bakery) – undeclared soy (2020)

The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.

Class IIModerate

FDAJul 23, 2020IN, WA• San Francisco Street Bakery Inc.

Baby Iron + Immunity (UpSpring) – undeclared milk (2020)

Undeclared Milk

May contain undeclared milk

FDAJul 23, 2020Nationwide• Upspring,ltd

Plain Bagel (San Francisco Street Bakery) – Undeclared Soy (2020)

The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.

Class IIModerate

FDAJul 23, 2020IN, WA• San Francisco Street Bakery Inc.

Cinnamon Raisin Bagel (San Francisco Street Bakery) – undeclared soy (2020)

The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.

Class IIModerate

FDAJul 23, 2020IN, WA• San Francisco Street Bakery Inc.

Garlic Bagel (San Francisco Street Bakery) – undeclared soy (2020)

The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.

Class IIModerate

FDAJul 23, 2020IN, WA• San Francisco Street Bakery Inc.

Onion Bagel (San Francisco Street Bakery) – undeclared soy (2020)

The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.

Class IIModerate

FDAJul 23, 2020IN, WA• San Francisco Street Bakery Inc.

Salt Bagel (San Francisco Street Bakery) – Undeclared Soy (2020)

The firm used pan release spray, which contains soy lecithin, on equipment and finished products labels do not declare soy lecithin.

Class IIModerate

FDAJul 23, 2020IN, WA• San Francisco Street Bakery Inc.

Leucovorin Calcium Tablets (West-Ward) – Incorrect Imprint (2020)

Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.

FDAJul 22, 2020MS, OH• West-Ward Columbus Inc

Dexmedetomidine HCl Injection (Fresenius Kabi) – Contamination Risk (2020)

Cross Contamination with other products: trace amounts of lidocaine

FDAJul 22, 2020Nationwide• Fresenius Kabi USA, LLC

Mibelas 24 Fe (Lupin) – Impurity Specification Failure (2020)

Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.

Class IIModerate

FDAJul 21, 2020Nationwide• Lupin Pharmaceuticals Inc.

DDAVP Nasal Spray (Ferring) – Superpotent Drug (2020)

Superpotent Drug

FDAJul 21, 2020Nationwide• Ferring Pharmaceuticals Inc

STIMATE Nasal Spray (Ferring) – Superpotent Drug (2020)

Superpotent Drug

FDAJul 21, 2020Nationwide• Ferring Pharmaceuticals Inc

Desmopressin Acetate Nasal Spray (Ferring) – Superpotent Drug (2020)

Superpotent Drug

FDAJul 21, 2020Nationwide• Ferring Pharmaceuticals Inc

Fentanyl Citrate Injection (Pfizer) – Sterility Concern (2020)

Lack of Assurance of Sterility; potential loose metal overseal crimp defects.

Class IIModerate

FDAJul 20, 2020Nationwide• Pfizer Inc.

Clobetasol Propionate Cream (Taro) – Content Uniformity Issue (2020)

Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.

FDAJul 20, 2020Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Lisinopril Tablets (Lupin) – Tablet Mix-up (2020)

Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg

Class IIModerate

FDAJul 17, 2020Nationwide• Lupin Pharmaceuticals Inc.

Dietary Supplements (Provident Nutraceutical) – Undeclared Soy (2020)

Various branded dietary supplements may contain undeclared soy.

Class IIModerate

FDAJul 16, 2020CA, FL, OH +2 more• Provident Nutraceutical div. of Ortho Molecular Products Inc

Lidocaine Patch (Teva) – Labeling Deficiency (2020)

Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.

Class IIModerate

FDAJul 14, 2020Nationwide• Teva Pharmaceuticals USA

Hydrocortisone Butyrate Cream (Bausch) – Subpotent Drug (2020)

SUBPOTENT DRUG

Class IIModerate

FDAJul 13, 2020Nationwide• Bausch Health Companies, Inc.

Fosaprepitant Injection (Fresenius) – Labeling Mistake (2020)

Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.

FDAJul 13, 2020Nationwide• Fresenius Kabi USA, LLC

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