D-0237-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 31, 2018
- Initiation Date
- January 9, 2018
- Termination Date
- May 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 205,088,000 tablets
Product Description
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-114-30.
Reason for Recall
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Distribution Pattern
Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
Code Information
Lot #: 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, HJ6112, Exp 02/18; HJ6113, HJ6114, HJ6115, HJ6116, HJ6117, HJ6118, HJ6119, HJ6120, HJ6121, HJ6122, HJ6123, HJ6124, HJ6125, HJ6126, HJ6127, HJ6128, HJ6129, HJ6130, HJ6131, HJ6132, HJ6133, HJ6134, HJ6135, HJ6136, Exp 03/18; 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, HJ6175, Exp 04/18; 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, HJ6203, Exp 05/18; HJ6204, HJ6025, HJ6206, HJ6207, HJ6208, HJ6209, HJ6210, HJ6211, HJ6212, HJ6213, HJ6214, HJ6215, Exp 06/18; HJ6216, HJ6217, HJ6218, HJ6219, HJ6220, Exp 08/18