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Expansive Ibuprofen Recall

February 01, 2018

Marksans Pharma Inc. is recalling hundreds of lots of ibuprofen in over-the-counter and prescription strengths because of odor complaints, according to the January 31, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The voluntary recall was initiatied by Marksans Pharma January 9, 2018. A week ago, the FDA designated it Class II, signaling use of the affected tablets could cause temporary or reversible adverse effects, with a remote probability of serious harm.

The following dosages are included in the recall:

  • 200-mg ibuprofen tablets (NDC 25000-136-20), from lots HI6001, HI6002, and HI6003 (Exp. 2/18);
  • 200-mg ibuprofen tablets (NDC 25000-114-30) from lots HJ6080, HJ6081, HJ6082, HJ6083, HJ6084, HJ6085, HJ6086, HJ6087, HJ6088, HJ6089, HJ6090, HJ6091, HJ6092, HJ6093, HJ6094, HJ6095, HJ6096, HJ6097, HJ6098, HJ6099, HJ6100, HJ6101, HJ6102, HJ6103, HJ6104, HJ6105, HJ6106, HJ6107, HJ6108, HJ6109, HJ6110, HJ6111, and HJ6112 (Exp 2/18), HJ6113, HJ6114, HJ6115, HJ6116, HJ6117, HJ6118, HJ6119, HJ6120, HJ6121, HJ6122, HJ6123, HJ6124, HJ6125, HJ6126, HJ6127, HJ6128, HJ6129, HJ6130, HJ6131, HJ6132, HJ6133, HJ6134, HJ6135, and HJ6136 (Exp 3/18), HJ6137, HJ6138, HJ6139, HJ6140, HJ6141, HJ6142, HJ6143, HJ6144, HJ6145, HJ6146, HJ6147, HJ6148, HJ6149, HJ6150, HJ6151, HJ6152, HJ6143, HJ6154, HJ6155, HJ6156, HJ6157, HJ6158, HJ6159, HJ6160, HJ6161, HJ6162, HJ6163, HJ6164, HJ6165, HJ6166, HJ6167, HJ6168, HJ6169, HJ6180, HJ6171, HJ6172, HJ6173, HJ6174, and HJ6175 (Exp. 4/18), HJ6176, HJ6177, HJ6178, HJ6179, HJ6180, HJ6181, HJ6182, HJ6183, HJ6184, HJ6185, HJ6186, HJ6187, HJ6188, HJ6189, HJ6190, HJ6191, HJ6192, HJ6193, HJ6194, HJ6195, HJ6196, HJ6197, HJ6198, HJ6199, HJ6200, HJ6201, HJ6202, and HJ6203 (Exp. 5/18), HJ6204, HJ6025, HJ6206, HJ6207, HJ6208, HJ6209, HJ6210, HJ6211, HJ6212, HJ6213, HJ6214, and HJ6215 (Exp. 6/18), HJ6216, HJ6217, HJ6218, HJ6219, and HJ6220 (Exp. 8/18);
  • 200-mg ibuprofen capsule-shaped tablets (NDC 25000-117-30) from lots HH6001 and HH6002 (Exp. 4/18);
  • 400-mg ibuprofen tablets (NDC 25000-121-29) from lots HK6001, HK6002, HK6003, HK6004, HK6005, HK6006, HK6007, HK6008, HK6009, HK6010, HK6011, HK6012, HK6013, HK6014, and HK6015 (Exp. 9/18);
  • 600-mg ibuprofen tablets (NDC 25000-122-28) from lots HN6004, HN6005, HN6006, HN6007, HN6008, HN6009, HN6010, HN6011, HN6012, HN6013, and HN6014 (Exp. 3/18), HN6015, HN6016, HN6017, HN6018, HN6019, HN6020, HN6021, HN6022, and HN6023 (Exp. 4/18), HN6024 (Exp. 7/18), HN6025, HN6026, and HN6027 (Exp. 9/18); and
  • 800-mg ibuprofen tablets (NDC 25000-123-27) from lots HM6067, HM6068, HM6069, HM6070, HM6072, HM6072, HM6073, HM6074, HM6075, HM6076, HM6077, HM6078, HM6079, HM6080, HM6081, HM6082, HM6083, HM6084, HM6085, HM6086, HM6087, HM6088, HM6089, HM6090, HM6091, HM6092, HM6093, HM6094, HM6095, and HM6096 (Exp. 2/18), HM6097, HM6098, and HM6099 (Exp. 3/18), HM6100, HM6101, HM6102, HM6103, HM6104, HM6105, HM6106, HM6107, HM6108, HM6109, HM6110, HM6111, HM6112, HM6113, HM6114, HM6115, HM6116, HM6117, HM6118, HM6119, HM6120, HM6121, HM6122, HM6123, HM6124, HM6125, HM6126, HM6127, HM6128, HM6129, HM6130, HM6131, and HM6132 (Exp. 8/18), HM6133, HM6134, HM6135, HM6136, HM6137, HM6128, and HM6139 (Exp. 9/18).

Manufactured by Marksans Pharma in India, the ibuprofen was repackaged in New York and subsequently distributed across the United States.

Ibuprofen is a nonsteroidal anti-inflammatory drug used to relieve pain, fever, and inflammation.

Jolynn Tumolo

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