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Hospira, Inc.

Complete recall history across all FDA and CPSC categories — 12 total recalls

Recall Summary

11 Drug Recalls 1 Device Recalls

Hospira, Inc. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (11)

FDA drug safety enforcement actions by Hospira, Inc.

Date Product Reason Class
Aug 25, 2015 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservati... Presence of Particulate Matter: particulate matter identified as iron oxide, ... Class II
Sep 16, 2013 Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage ... Lack of Assurance of Sterility: Confirmed customer report of leakage of vial ... Class II
Sep 16, 2013 1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., L... Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% ... Class I
Aug 12, 2013 Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Fo... Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied ... Class II
May 20, 2013 Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, ... Presence of Particulate; lot being recalled as a precaution due to the discov... Class II
Jan 10, 2013 Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hosp... Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial Class II
Nov 21, 2012 Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only... Lack of Assurance of Sterility: Complains of a loose crimp applied to the fli... Class II
Oct 4, 2012 Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, ... Presence of Particulate Matter: Report of a vial containing visible particula... Class II
Jun 21, 2012 Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, ... CGMP Deviations: Shipment of product not approved for release. Class III
Apr 11, 2012 Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 U... Presence of Particulate Matter: A single visible particulate was observed in ... Class II
Apr 5, 2012 Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g t... Superpotent (Single Ingredient) Drug: Above specification assay results for p... Class III

Device Recalls (1)

FDA medical device enforcement actions by Hospira, Inc.

Date Product Reason Class
Aug 2, 2012 Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-0... Reports of leaking during filling and administration. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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