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Showing 4121–4140 of 14370 results

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Headache Relief Tablets (Ultra Seal) – stability specification failure (2020)

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

FDAAug 3, 2020IL, IN, TX• Ultra Seal Corporation

Specialty Italian Hoagie (Giant Eagle) – Salmonella Contamination (2020)

Potential contamination with Salmonella Newport in onions and prepared foods containing onions.

FDAAug 2, 2020IN, MD, OH +2 more• Giant Eagle

Cajun Chicken Meal (Giant Eagle) – Salmonella Risk (2020)

Salmonella

Potential contamination with Salmonella Newport in onions and prepared foods containing onions.

Class IIModerate

FDAAug 2, 2020IN, MD, OH +2 more• Giant Eagle

Stuffed Turkey Breast (Giant Eagle) – Salmonella Risk (2020)

Potential contamination with Salmonella Newport in onions and prepared foods containing onions.

Class IIModerate

FDAAug 2, 2020IN, MD, OH +2 more• Giant Eagle

Stuffing Balls (Giant Eagle) – Salmonella risk (2020)

Potential contamination with Salmonella Newport in onions and prepared foods containing onions.

Class IIModerate

FDAAug 2, 2020IN, MD, OH +2 more• Giant Eagle

Stuffed Bone-In Chicken Breast (Giant Eagle) – Salmonella Contamination (2020)

Potential contamination with Salmonella Newport in onions and prepared foods containing onions.

Class IIModerate

FDAAug 2, 2020IN, MD, OH +2 more• Giant Eagle

Stuffed Boneless Chicken Breast (Giant Eagle) – Salmonella Contamination (2020)

Potential contamination with Salmonella Newport in onions and prepared foods containing onions.

Class IIModerate

FDAAug 2, 2020IN, MD, OH +2 more• Giant Eagle

Deluxe Italian Party Hoagie (Giant Eagle) – Salmonella Risk (2020)

Potential contamination with Salmonella Newport in onions and prepared foods containing onions.

FDAAug 2, 2020IN, MD, OH +2 more• Giant Eagle

Jaloma Hand Sanitizer (Laboratorios Jaloma) – manufacturing deviation (2020)

cGMP deviations

Class IIModerate

FDAJul 31, 2020Nationwide• Laboratorios Jaloma S.A. de C.V.

Assured Vitamin E Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Heparin Sodium 5,000 Units (SCA) – Subpotent Drug (2020)

Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.

Class IIModerate

FDAJul 29, 2020Nationwide• SCA Pharmaceuticals

Heparin Sodium 2,500 Units (SCA) – Undeclared Preservatives (2020)

Undeclared Allergen

Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

FDAJul 29, 2020Nationwide• SCA Pharmaceuticals

Heparin Sodium 10,000 Units (SCA) – Undeclared Preservatives (2020)

Undeclared Allergen

Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

FDAJul 29, 2020Nationwide• SCA Pharmaceuticals

Heparin Sodium 5,000 Units (SCA) – Undeclared Preservatives (2020)

Undeclared Allergen

Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

FDAJul 29, 2020Nationwide• SCA Pharmaceuticals

Heparin Sodium 5,000 Units (SCA) – Undeclared Preservatives (2020)

Undeclared Allergen

Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.

FDAJul 29, 2020Nationwide• SCA Pharmaceuticals

Phentermine 15mg (Calvin Scott) – Light Sensitivity Packaging (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Phentermine HCL Blue/White Capsules (Calvin Scott) – Light Sensitivity Risk (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Phentermine HCL 30mg (Calvin Scott) – Light Sensitivity Packaging (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Thyroid Neutral Tabs (Calvin Scott) – Light Sensitivity Risk (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

Phendimetrazine 35mg (Calvin Scott) – Light Sensitivity Packaging (2020)

CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.

Class IIModerate

FDAJul 27, 2020Nationwide• Calvin Scott & Company, Inc.

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