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Showing 4981–5000 of 29086 results

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Boric Acid Capsules (Wedgewood) - Unsanitary Conditions (2022)

Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Class IIModerate

FDAJun 10, 2022Nationwide• Wedgewood Village Pharmacy, LLC

Calcipotriene Scalp Solution (Akorn) - Defective Delivery (2022)

Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.

Class IIModerate

FDAJun 10, 2022Nationwide• Akorn, Inc.

Losartan/Hydrochlorothiazide (Macleods) - Impurity Levels (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAJun 10, 2022Nationwide• Macleods Pharma Usa Inc

Bethanechol Chloride Suspension (Wedgewood) - Unsanitary Conditions (2022)

Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Class IIModerate

FDAJun 10, 2022Nationwide• Wedgewood Village Pharmacy, LLC

Doxycycline Suspension (Wedgewood) - Unsanitary Conditions (2022)

Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Class IIModerate

FDAJun 10, 2022Nationwide• Wedgewood Village Pharmacy, LLC

Estriol Vaginal Cream (Wedgewood) - Unsanitary Conditions (2022)

Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection

Class IIModerate

FDAJun 10, 2022Nationwide• Wedgewood Village Pharmacy, LLC

Belle Vie Sparkling Water (Independent Beverage) – Undeclared Caffeine (2022)

Undeclared Allergen

Firm indicated that the product contains undeclared caffeine.

Class IIModerate

FDAJun 10, 2022CT, FL, GA +14 more• Independent Beverage Company LLC

Clonidine Patch (Mayne Pharma) - Delivery System Defect (2022)

Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.

Class IIModerate

FDAJun 9, 2022Nationwide• Mayne Pharma Inc

Qassim Coffee Mix (Tomoorona) – Undeclared Milk (2022)

The product is labeled to contain sodium caseinate, a milk derivative, but the label does not declare the product contains "milk."

Class IIModerate

FDAJun 9, 2022GA, IN, KS +1 more• Tomoorona LLC

Milk of Magnesia USP (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

CorrectDose Children's Pain Relief (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Diphenhydramine HCl Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Milk of Magnesia USP (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Magnesium Aluminum Simethicone (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Children's Cough Syrup (Plastikon) - Manufacturing Deviation (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Guaifenesin Dextromethorphan Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

CorrectDose Children's Allergy Relief (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Acetaminophen Oral Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Calcium Carbonate Suspension (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

Acetaminophen Oral Solution (Plastikon Healthcare) – Manufacturing Quality Issue (2022)

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

Class IIModerate

FDAJun 7, 2022Nationwide• Plastikon Healthcare LLC

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