Hospira 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic recall — FDA D-176-2013
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Complete FDA and NHTSA recall records dated in 2013, organized for browsing by month, category and recalling company.
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Records are ordered by the best available source date.
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.
Subpotent; bupivacaine
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.
Marketed Without an Approved NDA/ANDA: All lots of the dietary supplement Slimdia Revolution are being recalled because they contain sibutramine, a previously approved FDA drug removed from…
Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.
Microbial Contamination of a Non-Sterile Products: 12-Hour Sinus Nasal Spray under various labeling are being recalled due to microbial contamination identified during testing.
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Crystallization: Recall is due to a non-characteristic gritty/sandy texture to the product which is likely due to some crystallization of the product.
Presence of Foreign Substance: Uncharacteristic blacks spots on tablets.
Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets.
Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point.
Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled.
Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia.
Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.