Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually labeled poly envelopes (primary packaging). Repackaged by Pine Pharmaceuticals, Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150, Office Use Only, Not for Resale. Secondary packaging consists of a coated cardboard box, with order-specific label indicating lot number housed within order/container. NDC # 69194-0458-1
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Reason Lack of Assurance of Sterility
Reason Failed Impurities/Degradations Specifications
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Reason Lack of Assurance of Sterility
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.