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Ciprofloxacin Injection (Claris) – Sterility Breach (2017)

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

Class IIModerate

FDAMar 10, 2017Nationwide• Claris Lifesciences Inc

RegeneFit (VivaCeuticals) – Manufacturing Compliance (2017)

The firm is recalling all herbal and dietary supplements because they were not manufactured in compliance with the current Good Manufacturing Practice regulations for Dietary Supplements.

Class IIModerate

FDAMar 9, 2017Nationwide

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Ciprofloxacin Injection (Claris) – Sterility Breach (2017)

RegeneFit (VivaCeuticals) – Manufacturing Compliance (2017)

RegenErect (VivaCeuticals) – Manufacturing Compliance (2017)

RegeneBoost (VivaCeuticals) – Manufacturing Compliance (2017)

RegeneSlim (VivaCeuticals) – Manufacturing Compliance (2017)

RegeneBlast (VivaCeuticals) – Manufacturing Compliance (2017)

RegeneBlend (VivaCeuticals) – Manufacturing Compliance (2017)

RegeneArouse (VivaCeuticals) – Manufacturing Compliance (2017)

Hydralazine Injection (Mckesson) – Temperature Abuse (2017)

Triamcinolone Injection (Isomeric) – CGMP Deviation (2017)

HU HU SHENG WEI Capsules (A&H Focal) – Unapproved Drug Content (2017)

Hard Ten Days Capsules (A&H Focal Inc.) - Undeclared Drug Ingredient (2017)

Quillivant XR 900mg (Pfizer) – Failed Dissolution (2017)

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

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

Quillivant XR Oral Suspension (Pfizer) – Dissolution Specification Failure (2017)

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

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

Lien Chan Seven Days Capsules (A&H Focal) – Unapproved Drug Content (2017)

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