Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule
Prescription Drugs
💊 Drugs • 12,141 recalls
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.
Crystallization; complaints received by the manufacturer of crystals forming in product
Lack of Assurance of Sterility
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy, San Antonio, TX 78247
Talon Compounding Pharmacy
Lack of Assurance of Sterility
Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
Teva North America
Superpotent drug: Out of specification test result for assay during stability testing.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related compound G were obtained at 12-month (at expiry) stability time-point for room temperature sample(s).
Remeven Cream, (50% Urea in a Cream Base), a) 5.0 oz (142 g) and b) 9.0 oz (255 g) tubes, Rx only, Manufactured by Sonar Products Inc, Carlstadt, NJ. Distributed by Stratus Pharmaceuticals Inc., Miami, FL.
Stratus Pharmaceuticals
Crystallization; Complaints that cream appears to have crystallized
Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Failed impurities/degradation specifications: product was out of specification for unknown impurity at the 9 month stability time point
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.