Ibuprofen Tablets recall: CGMP Deviations
Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans…
Why was Ibuprofen Tablets recalled?
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: HK6001, HK6002, HK6003, HK6004, HK6005, HK6006, HK6007, HK6008, HK6009, HK6010, HK6011, HK6012, HK6013, HK6014, HK6015, Exp 09/18
- Product
- Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans…
- Recalling firm
- Marksans Pharma Inc.
- Quantity
- 21,584,100 tablets
- Distribution
- Distributed to repackaging firms in NY who then distributed Nationwide in the USA.
- Recall date
- January 31, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)