Failed Dissolution Specifications: out of specification dissolution results in retained samples
All Recalls
95,094 total recalls in our database
Failed Dissolution Specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specification rates for the 10 hour testing point.
Venlafaxine Hydrochloride Extended-Release Capsules, 150 mg, a) 30 capsules per bottle, NDC # 60429-123-30, b) 90 capsules per bottle, NDC # 60429-123-90, Rx Only, GSMS.
Golden State Medical Supply
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Venlafaxine Hydrochloride Extended-Release Capsules, 75 mg, 90 capsules per bottle, Rx Only, GSMS, NDC # 60429-122-90
Golden State Medical Supply
Failed Dissolution Specifications: Out-of-specification results in retained sample.
Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants
Biomet 3i
Pouches may not have been sealed during packing.
Provide Protection Cap Dental implants
Biomet 3i
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.
A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than expected frequency of customer calibration curves falling outside of the calibration quality parameters and therefore unusable to process samples. Customers using VITROS TSH Lot 5040 will potentially experience an unexpected increase in the unsuccessful calibrations potentially causing a delay in testing and reporting results for VITROS TSH.
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Pouches may not have been sealed during packing.
The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.
Potential for compromise of the package resulting in a breach of the sterile barrier
Conical EP Healing Cap Dental implants
Biomet 3i
Pouches may not have been sealed during packing.
Potential for compromise of the package resulting in a breach of the sterile barrier
Pouches may not have been sealed during packing.
Pouches may not have been sealed during packing.