Chemical contamination; presence of benzene
All Recalls
95,018 total recalls in our database
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Failed Dissolution Specifications: results were above specification.
Chemical contamination; presence of benzene
Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, "WARNING: PARALYZING AGENT"
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-530-08.
Teva Pharmaceuticals USA
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
Chemical contamination; presence of benzene
cGMP Deviations
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-129-06.
Teva Pharmaceuticals USA
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
cGMP Deviations
Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-1
Dr. Reddy's Laboratories
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Chemical contamination; presence of benzene
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC, Frazer, PA 19355, Manufactured in Ireland, NDC 59310-136-06
Teva Pharmaceuticals USA
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale, Rx Only, Mktd by: Teva Respiratory, LLC , Frazer, PA 19355, Manufactured in Ireland, NDC 59310-520-08
Teva Pharmaceuticals USA
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol
CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues.
SIGNA Pioneer nuclear magnetic resonance imaging system
GE Healthcare
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000 (01)00840001405868
Implant Resource
Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected
Foundation Kit
Stradis Medical, LLC
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852
Limacorporate S.p.A
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.