CGMP Deviations
All Recalls
95,089 total recalls in our database
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
CGMP Deviations
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06
Stason Pharmaceuticals
Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
CGMP Deviations
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
CGMP Deviations
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Bromocriptine Mesylate Capsules USP, 5 mg, 30-count bottles, Rx only, Manufactured by: Cadila Healthcare ltd., Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-110-06
Zydus Pharmaceuticals USA
Failed impurities/degradation specifications: Out of specification results noticed in related substance test during analysis of 24 months long term (25 degree Celsius /65% RH) stability samples of two batches.
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,
Isomeric Pharmacy Solution
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.