Marksans Pharma recalls
FDA enforcement reports naming Marksans Pharma Inc. as the recalling firm.
- Recall reports
- 9
- Class I (serious)
- 0
- Most recent report
- Nov 11, 2020
- Nov 11, 2020Time-Cap Labs, IncDrug · Marksans Pharma LimitedCGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelClass II
- Nov 11, 2020Time-Cap Labs, IncDrug · Marksans Pharma LimitedCGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelClass II
- Jul 1, 2020Time-Cap Labs, IncDrug · Marksans Pharma LimitedCGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelClass II
- Jan 31, 2018Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper p…Drug · Marksans Pharma Inc.CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.Class II
- Jan 31, 2018Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in…Drug · Marksans Pharma Inc.CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.Class II
- Jan 31, 2018Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper p…Drug · Marksans Pharma Inc.CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.Class II
- Jan 31, 2018Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper p…Drug · Marksans Pharma Inc.CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.Class II
- Jan 31, 2018Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper p…Drug · Marksans Pharma Inc.CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.Class II
- Jan 31, 2018Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper p…Drug · Marksans Pharma Inc.CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.Class II