Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
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Prescription Drugs
💊 Drugs • 12,141 recalls
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
RXQ Compounding
Class I - Dangerous
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01
Boehringer Ingelheim Pharmaceuticals
Class I - Dangerous
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Class I - Dangerous
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Class I - Dangerous
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Class I - Dangerous
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Class I - Dangerous
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01.
Teva Pharmaceuticals USA
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
Class I - Dangerous
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
Failed Dissolution Specifications
Failed Dissolution Specifications
CGMP Deviations: Product manufactured for Industrial Use but was labeled and distributed for Pharmacy Compounding Use.
Class I - Dangerous
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class I - Dangerous
Labeling: Not Elsewhere Classified- Diluent used to compound product expired prior to the expiration date assigned to the compounded product.
Class I - Dangerous
Non-Sterility:presence of cracked or chipped glass at the neck of Sterile Water for Injection vials.
Class I - Dangerous
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.