Class I - Dangerous
Failed Impurity/Degradation Specifications
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Prescription Drugs
💊 Drugs • 11,927 recalls
Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class I - Dangerous
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Class I - Dangerous
CGMP Deviations
Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232
SCA Pharmaceuticals
Class I - Dangerous
Subpotent drug.
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
Morton Grove Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Class I - Dangerous
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
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