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Rifampin Injection (Mylan) – Impurity Degradation (2019)

Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product.

Class IIModerate

FDAOct 7, 2019Nationwide• Mylan Laboratories Limited (Sterile Products Division)

Methylphenidate HCl Oral Solution (KVK-Tech) – Foreign Substance (2019)

Presence of Foreign Substance; Fiber particles.

Class IIILow

FDAOct 4, 2019Nationwide• KVK-Tech, Inc.

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Rifampin Injection (Mylan) – Impurity Degradation (2019)

Methylphenidate HCl Oral Solution (KVK-Tech) – Foreign Substance (2019)

10% LMD in 5% Dextrose (Pfizer) – Sterility and Leak Risk (2019)

Sankaijo Botanical Laxative (Sato) – Subpotent Formulation (2019)

Ranitidine Capsules 300mg (Dr. Reddy's) – NDMA Impurity (2019)

Zentrip Strips (Sato) – Subpotent Drug (2019)

Motion Sickness Tablets (Sato) – Subpotent Drug (2019)

Motion Sickness Strips (Sato) – Subpotent Drug (2019)

Ranitidine Capsules 150mg (Dr. Reddy's) – NDMA Impurity (2019)

WAL-DRAM 2 Tablets (Sato) – Subpotent Drug (2019)

Ibuprofen Oral Suspension (Taro) – plastic particles (2019)

Children's Ibuprofen Suspension (Taro) – foreign substance (2019)

Ibuprofen Oral Suspension (Taro) – plastic contamination (2019)

Testosterone Cypionate Injection (Arbor) – label mix-up (2019)

Children's Ibuprofen Suspension (Taro) – manufacturing debris (2019)

Children's Ibuprofen Suspension (Taro) – particle risk (2019)

CELLECT Cell Synergy (Cellect Products) – Heavy Metal Risk (2019)

Estradiol Tablets (Epic) – dosage mix-up (2019)

Vivitrol (Alkermes) – incorrect needle packaging (2019)

Kenzen Calcium Complex (HP Ingredients) – Mislabeling Issue (2019)