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Phentermine HCL Capsules (KVK-Tech) – Impurity Specification (2017)

Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.

Class IIILow

FDAAug 3, 2017Nationwide• KVK-Tech, Inc.

Glipizide Extended-Release Tablets (Teva) – Moisture Limit Failure (2017)

Failed Moisture Limits: out of specification test results for water content obtained during stability testing.

Class IIILow

FDAAug 2, 2017CT, IL, MI +3 more• Teva Pharmaceuticals USA

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Phentermine HCL Capsules (KVK-Tech) – Impurity Specification (2017)

Glipizide Extended-Release Tablets (Teva) – Moisture Limit Failure (2017)

Albuterol Sulfate Inhalation Solution (Teva) – Impurity Specification Failure (2017)

Grandma's Herbs Cholesterol Support (Grandma's Herbs) – Undeclared soy (2017)

Voriconazole Tablets (AVKARE) – Impurity Specification Failure (2017)

Make Up Perfect Pastel SPF 10 (Linde Eckstein) - Subpotent Protection (2017)

Make Up Transparent Dark Tan (Linde Eckstein) – Subpotent SPF Protection (2017)

Make Up Transparent Sand (Linde Eckstein) – Subpotent SPF Protection (2017)

Make Up Transparent Terra (Linde Eckstein) – Subpotent SPF Protection (2017)

Beautipharm Body Moisturizing Balm (Linde Eckstein) – Subpotent SPF Protection (2017)

Make Up Transparent Ivory (Linde Eckstein) – Subpotent SPF Protection (2017)

Beautipharm All Day Moisturizing Balm (Linde Eckstein) – Subpotent SPF Protection (2017)

Make Up Perfect Ivory (Linde Eckstein) – Subpotent SPF Protection (2017)

Make Up Perfect Caramel (Linde Eckstein) – Subpotent SPF Protection (2017)

Make Up Perfect Dark Tan (Linde Eckstein) – Subpotent SPF Protection (2017)

Eye Care Balm SPF 10 (Linde Eckstein) - Subpotent Protection (2017)

Make Up Perfect Sand (Linde Eckstein) – Subpotent SPF Protection (2017)

Make Up Transparent Pastel (Linde Eckstein) – Subpotent SPF Protection (2017)

Make Up Perfect Terra SPF 10 (Linde Eckstein) - Subpotent Protection (2017)

Chlorhexidine Gluconate Oral Rinse (Akorn) – Crystallization Risk (2017)