Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Manufactured by Hospira Australia 1 Lexia Place, Mulgrave, Victoria Australia 3170. NDC 61703-327-22.
Compare with the code on your package — it is the most precise check available.
Drug: Dacarbazine
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Lack of Assurance of Sterility
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Presence of Particulate Matter: human hair found within an internal sample syringe.
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Discoloration: Firm received complaints of product discoloration and particulates.
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Free recall alerts
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.