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Promethazine Codeine Syrup (Qualitest) – Impurity Concern (2015)

Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.

Class IIILow

FDAMar 25, 2015Nationwide• Qualitest Pharmaceuticals

Fluorescein Sodium Strips (Nomax) – Dosage Uniformity (2015)

Failed Content Uniformity Specifications: The product may not meet finished product release specifications, including the uniformity of dosage due to a packaging degradation related to the adhesive component of the paper pouch that can impact the level of fluorescein present in the strips.

Class IIILow

FDA

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Promethazine Codeine Syrup (Qualitest) – Impurity Concern (2015)

Fluorescein Sodium Strips (Nomax) – Dosage Uniformity (2015)

Rose Bengal Ophthalmic Strips (Nomax) – Dosage Uniformity (2015)

Fluorescein Sodium Strips (Nomax) – Dosage Uniformity (2015)

Chocolate Covered Peanuts (Essential Everyday) – Undeclared Raisins (2015)

Hacizade Pismaniye Pashmak (Turkana Food) - Color Additive Concern (2015)

Fexofenadine HCl Tablets (Mylan) – Impurity Concern (2015)

Medical Air (Matheson) – CO2 Specification Failure (2015)

Quinapril 40mg Tablets (AVKARE) – Subpotent Medication (2015)

Quinapril 5mg Tablets (AVKARE) – Subpotent Medication (2015)

Oxecta Oxycodone 7.5mg Tablets (Pfizer) – Impurity Degradation (2015)

Bunny Head Cookies (Cheryls) – Incorrect Packaging (2015)

Oxecta Oxycodone 5mg Tablets (Pfizer) – Impurity Degradation (2015)

Fentanyl Citrate Injection (West-Ward) – Degradation Specs (2015)

LaRosa's Italian Dressing (T. Marzetti) – labeling issue (2015)

Z-COTE HP 1 Transparent Zinc Oxide (Nanophase) – Illegible Label (2015)

Bromfenac Ophthalmic Solution (Apotex) – Excipient Testing Issue (2015)

Doxorubicin Injection (Mylan) – Product Mispack (2015)

Southern Heat Medium Salsa (Creative Foodworks) – Undeclared Peanuts (2015)

Aleia's Parmesan Croutons (Aleias) – Peanut protein risk (2015)