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GOLD VIGRA Capsules (A&H Focal Inc.) - Undeclared Drug Ingredient (2017)

Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.

Class IHigh

FDAMar 7, 2017NJ, NY• A&H Focal Inc.

Adalat CC Tablets 60mg (Alvogen) – Cross Contamination (2017)

Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Class IIILow

FDAMar 7, 2017Nationwide• Alvogen, Inc

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GOLD VIGRA Capsules (A&H Focal Inc.) - Undeclared Drug Ingredient (2017)

Adalat CC Tablets 60mg (Alvogen) – Cross Contamination (2017)

Clalis Capsules (A&H Focal Inc.) - Undeclared Drug Ingredient (2017)

Ye Lang Shen Capsules (A&H Focal) – Unapproved Drug Content (2017)

Miraculous Evil Root Capsules (A&H Focal) – Unapproved Drug Content (2017)

Nifedipine 60mg Tablets (Alvogen) – Cross Contamination (2017)

Black Ant Capsules (A&H Focal) – Unapproved Drug Content (2017)

Nifedipine Extended-Release Tablets (Alvogen) – Cross Contamination (2017)

Yanshijiaonang Capsules (A&H Focal) – Unapproved Drug Content (2017)

Adalat CC Tablets 60mg (Alvogen) – Cross Contamination (2017)

Quillivant XR 750mg (Pfizer) – Failed Dissolution (2017)

Max Man Capsules (A&H Focal Inc.) - Undeclared Drug Ingredient (2017)

Atenolol Tablets (Legacy Pharmaceutical) - Foreign Tablet Mix-up (2017)

Adalat CC Tablets (Alvogen) - Cross Contamination Risk (2017)

Rivastigmine Capsules (Dr. Reddy's) - Cross-Contamination Risk (2017)

Atenolol Tablets (Zydus Pharmaceuticals) - Foreign Tablet Mix-up (2017)

Desonide Ointment (Fougera) - Labeling Mix-up (2017)

Clindamycin Solution (G & W Laboratories) - Expired Ingredient (2017)

Penicillin V Tablets (Citron Pharma) - Foreign Tablet Mix-up (2017)

Aspirin Chewable Tablets (Mckesson) - Foreign Material Risk (2017)