CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
All Recalls
95,018 total recalls in our database
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP deviations: tablets cracking
The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-012-02
Best Brands Consumer Products
Chemical Contamination; FDA analysis found product to contain benzene
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Failed Dissolution Specifications
Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32
SCA Pharmaceuticals
CGMP Deviations
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
There is a potential for foreign matter.
ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
Siemens Healthcare Diagnostics
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
TRAY RING COVER, REF OM271000, CONTAINS (1) TRAY RING COVER, STERILE R, Rx Only,
Johnson & Johnson Surgical Vision
Potential breach in the sterility barrier for tray ring covers.
K-Wire, 1.35 mm x 170 mm
Arthrex
Products do not meet length and diameter specifications.
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
Siemens Healthcare Diagnostics
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Restrata, Part Number RWM1-2X2
Acera Surgical
Misprinted expiration date on the shelf-box
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Siemens Healthcare Diagnostics
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.
Olympus Corporation of the Americas
GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients