Class I - Dangerous
Failed Dissolution Specifications - low dissolution results
MYLAN PHARMACEUTICALS
Labeling: Missing label: Label missing from some prefilled pens.
Labeling: Missing label on the vial
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Class I - Dangerous
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
cGMP deficiencies
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Out-of-specification organic impurity results obtained during routine stability testing.
Class I - Dangerous
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Class I - Dangerous
Presence of particulate matter. presence of metal particles.
Class I - Dangerous
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class I - Dangerous
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class I - Dangerous
Presence of Foreign Substance
Class I - Dangerous
Failed Dissolution Specification: Low out of specification dissolution results.
Class I - Dangerous
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Class I - Dangerous
Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 DrNatura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 and Item# 46017-088-18 DrNatura Toxinout Kit lot 005983-001 Expiry Dec 2018 . The products are being recalled due to undeclared soy allergen statement.
Class I - Dangerous
Mylan Consumer Healthcare has decided to initiate recall of the following products : Item# 46017-088-04 Dr Natura Flora Protect Probiotics lot 3020068 Expiry Mar 2019 . The products are being recalled due to undeclared soy allergen statement.
Defective Container: Potential for broken glass in the neck area of the glass bottles.
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
CGMP Deviations
Class I - Dangerous
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Class I - Dangerous
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Class I - Dangerous
Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; out of specification results for Sulphoxide Impurity and Total Impurities
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Class I - Dangerous
Failed Dissolution Specifications
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
Class I - Dangerous
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Class I - Dangerous
Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 mg tablets
Failed Impurities/Degradation Specifications: OOS results for known compound.
Class I - Dangerous
Failed Dissolution Specifications; three month stability time point.
Class I - Dangerous
Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.
Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.
Class I - Dangerous
Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
Class I - Dangerous
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Class I - Dangerous
Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Class I - Dangerous
Subpotent Drug: Assay results obtained during stability testing for Levothyroxine Sodium Tablets, USP were below specification.
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class I - Dangerous
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class I - Dangerous
Labeling: Label Error on Declared Strength- Unopened bottles of Ropinirole USP 3 mg tablets was found to be incorrectly labeled as Ropinirole USP 4 mg tablets..
Class I - Dangerous
Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..
Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets.
Class I - Dangerous
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
Class I - Dangerous
Impurities/Degradation Products: Out of specification results for Related Compound during routine stability testing.
Class I - Dangerous
Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.