fda
9 records
FDA Drug Recall: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500 mg
2020-11-11
Class II — CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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FDA Drug Recall: Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 mg,
2020-11-11
Class II — CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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FDA Drug Recall: Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500 mg
2020-07-01
Class II — CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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FDA Drug Recall: Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag sh
2018-01-31
Class II — CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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FDA Drug Recall: Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk pa
2018-01-31
Class II — CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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FDA Drug Recall: Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag sh
2018-01-31
Class II — CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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FDA Drug Recall: Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag sh
2018-01-31
Class II — CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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FDA Drug Recall: Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag sh
2018-01-31
Class II — CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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FDA Drug Recall: Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag sh
2018-01-31
Class II — CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
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fda_adverse
1 records
FDA AE Manufacturer: MARKSANS PHARMA LIMITED
Drug adverse event reporter — Product: IBUPROFEN
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ny_corps
1 records
NY Corp: MARKSANS PHARMA INC.
2016-11-02
DOMESTIC BUSINESS CORPORATION | County: Suffolk | Jurisdiction: New York
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