Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Lack of Processing Controls (lack of assurance of conformity to specifications).
Class I - Dangerous
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.
Class I - Dangerous
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01
Lupin Pharmaceuticals
Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047; NDC 63323-972-10
Fresenius Kabi USA
Class I - Dangerous
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
Class I - Dangerous
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class I - Dangerous
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample