Reason: Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Distributed: Directly to patients and physicians in FL, NJ, NY, and Puerto RicoReason: Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Distributed: Directly to patients and physicians in FL, NJ, NY, and Puerto RicoReason: Failed Dissolution Specifications: Product was out of specification (OOS) at the 12 month long term stability testing point.
Distributed: Nationwide.Reason: Defective Container: Glass vials may crack due to low (thin) out of specification vial wall thickness which may lead to contamination and lack of assurance of sterility.
Distributed: Nationwide and Puerto Rico, Italy, Netherland, SpainReason: Labeling:Missing Label: Bottles may not have a product label, or have a label with missing or illegible lot number and/or expiry date.
Distributed: Nationwide.Reason: Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal
Distributed: NationwideReason: Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Distributed: Nationwide.Reason: Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Distributed: Nationwide and Puerto RicoReason: Does Not Meet Monograph: Chlorhexidine Gluconate Surgical Scrub Brush is being recalled due to higher concentrations of available chlorhexidine gluconate.
Distributed: Nationwide; Mexico, PhilippinesReason: Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Distributed: U.S. Nationwide Including Puerto Rico