Class I - Dangerous
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
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Prescription Drugs
💊 Drugs • 12,141 recalls
Class I - Dangerous
Failed Dissolution Specifications
Class I - Dangerous
Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.
Class I - Dangerous
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
Advanced Nutriceuticals
Class I - Dangerous
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class I - Dangerous
Failed Dissolution Specifications
cGMP deviations: Vials may not be sealed correctly affecting sterility.
Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, Rx Only, Mfd. by. West-ward Eatontown, NJ 07724 USA, Vial NDC 0641-0497-17
Hikma Pharmaceuticals USA
Class I - Dangerous
Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
SCA Pharmaceuticals
Class I - Dangerous
Subpotency: Out-of-specification stability test result for low potency was obtained.
Class I - Dangerous
CGMP Deviations
Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.
Shilpa Medicare Limited
Class I - Dangerous
CGMP Deviations
Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), packaged in cartons of 50 cartridges (1.7 mL each), Rx only, Manufactured for SEPTODONT, Inc., Louisville, CO 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, ON N1R 6X3, Canada, NDC 0362-1098-90
Novocol Pharmaceutical of Canada
Class I - Dangerous
Labeling: Label mix-up
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Cross Contamination with other products: trace amounts of lidocaine
Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.
Shilpa Medicare Limited
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
Failed Dissolution Specifications
ARIPIPRAZOLE TABLETS, 15 mg, 30-count. bottles, Rx Only, GSMS Incorporated, Manufactured by: Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS, Incorporated, Camarillo, CA 93012 USA, NDC #60429-449-30
Golden State Medical Supply
Class I - Dangerous
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60
Teligent Pharma
Class I - Dangerous
Superpotent and Subpotent; low and high assay results