Complete FDA and NHTSA recall records dated in 2013, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Presence of Precipitate; potential for incomplete constitution upon addition of diluent.
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Presence of Particulate Matter: Found during examination of retention samples.
Marketed Without An Approved NDA/ANDA: Lightning Rod capsules are being recalled because FDA analysis found it to contain an undeclared analogue of sildenafil. Sildenafil is the active…
Failed Dissolution Specifications: Dissolution test results at 8 hour time-point were above approved specification limits.
Labeling -label error on declared strength: unopened, sealed bottle of Terazosin Hydrochloride (HCl) 10mg Capsules contained Terazosin HCl 5 mg Capsules
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Defective container: products are packaged in pouches which may not have been fully sealed
Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomplete blister card cuts, and missing or incorrectly placed liquicaps within the blisters.
Marketed Without an Approved NDA/ANDA; product contains analogues of sildenafil and tadalafil which are active pharmaceutical ingredients in FDA-approved drugs used to treat erectile…
Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture…
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own…
Subpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Presence of Particulate Matter; particulate found in retain samples
Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have…
Subpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Microbial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
Lack of Assurance of Sterility; potential for mold contamination
Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine…
Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the…
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.
