Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
Aurobindo Pharma USA
Class I - Dangerous
Failed Impurities/ Degradation Specifications
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01
Hikma Pharmaceuticals USA
Class I - Dangerous
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I - Dangerous
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class I - Dangerous
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Class I - Dangerous
Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.
Class I - Dangerous
Subpotent drug - Product did not contain drug.
Class I - Dangerous
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Class I - Dangerous
Presence of Particulate Matter - found in reserve sample vials at the firm.
Class I - Dangerous
Presence of Particulate Matter: particulate matter identified after reconstitution.
Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11
American Health Packaging
Class I - Dangerous
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).
Class I - Dangerous
Some bottles may contain mixed strengths of the product.
NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-330-01.
Acella Pharmaceuticals
Class I - Dangerous
Superpotent Drug.
Class I - Dangerous
Some bottles may contain mixed strengths of the product.
Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
TRIOVA PHARMACEUTICALS
Class I - Dangerous
Failed impurities/ degradation specifications: Out of specification for organic impurities.
Class I - Dangerous
Presence of Foreign Substance consistent with granules from desiccant packs used during storage
Class I - Dangerous
Some bottles may contain mixed strengths of the product.
NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-329-01.
Acella Pharmaceuticals
Class I - Dangerous
Superpotent Drug.
Class I - Dangerous
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.