Class II · Moderate risk
Synjardy (empagliflozin and metformin hydrochloride)
Cross Contamination With Other Products:
Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it.
782 FDA drug recalls with this cause, newest first.
Cross-contamination means a product picked up traces of a different drug during manufacturing, repackaging or handling - usually because equipment or a facility was shared. Penicillin is the classic case: it is a potent allergen, so FDA requires it to be made in fully separate facilities, and a single lapse can put every product that passed through the same line on the recall list. Most of these recalls are precautionary sweeps of everything a firm handled during the affected period, which is why one event can add hundreds of entries at once.
Class II · Moderate risk
Loxapine Capsules
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Class II · Moderate risk
Loxapine Capsules
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Class III · Low risk
Triamterene and Hydrochlorothiazide Tablets
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Class II · Moderate risk
Divalproex Sodium Delayed Release Tablets USP
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Class III · Low risk
Fluocinonide Gel USP
Cross contamination with other products: traces of Dapsone were found in the finished product.
Class II · Moderate risk
Nose to Toes Skin Antisepsis
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Skin antisepsis and oral cleansing. Contains Three 2-packs of 2%…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q Care RX Petite Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Oral Cleansing & Suctioning System Suction Toothbrush…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Oral Cleansing & Suctioning System q8. Contains 1 Covered…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.CARE Oral Cleansing & Suctioning System q4. Contains 1 Covered Yankauer
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.CareOral Cleansing & Suctioning System q2. Contains 1 Covered…
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
Class II · Moderate risk
Q.Care Petite Size Oral Cleansing & Suctioning System. Contains 1 Covered Yankauer
Cross Contamination With Other Products: Oral care solutions were manufactured by a third party supplier on equipment shared with non-pharmaceutical products
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