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issued a recall of one lot of Infla-650 Herbal Dietary Capsules because they were found to contain acetaminophen, diclofenac, and phenylbutazone

Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER for Injection, USP, due to a Potential Lack of Sterility Assurance Hospira, Inc., a Pfizer company, is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the Hospital/Retail level

Phase 2 trial in type 2 diabetes (Lancet 2023) showed similar additive benefit for the combination

The applicant provided five documents to support these claims, which included three studies and two FDA communications concerning reusable, reprocessed urological endoscopes