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Warning letters, 483s, Recalls, Import Alerts, Audit observations

Hospira Inc., a Pfizer company announced recall of several injectable products in US for potential glass particulates in vials.

Three of the products recalled are 4.2% Sodium Bicarbonate Injection (NDC 0409-5534-24); 8.4% Sodium Bicarbonate Injection (NDC 0409-6637-24); Atropine Sulfate Injection (NDC 0409-4911-11). The recalls were initiated due to the potential for presence of glass particulate matter, identified during product inspection. Another recall of Bleomycin for Injection (NDC 61703-332-18) was initiated due to a confirmed customer report for the presence of glass particulate within a single vial of the product.

Recall Intimation 4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection

Recall Intimation Bleomycin for Injection

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