FDA (Drugs) recall action 79349
The FDA (Drugs) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
The agency’s own wording, quoted from the enforcement report.
Time-Cap Laboratories is recalling various strengths of ibuprofen tablets due to odor complaints related to CGMP deficiencies.
Time-Cap Laboratories is recalling specific lots of Ibuprofen 800 mg tablets due to odor complaints linked to CGMP deficiencies.
Time-Cap Laboratories is recalling specific bottles of Ibuprofen 200 mg caplets due to odor complaints linked to CGMP deficiencies.
Time-Cap Laboratories is recalling specific lots of 800 mg ibuprofen tablets due to odor complaints linked to CGMP deficiencies.
Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 400 mg due to odor complaints related to Current Good Manufacturing Practice (CGMP) deficiencies.
Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 600 mg due to odor complaints linked to CGMP deficiencies.
Time-Cap Laboratories is recalling specific lots of Ibuprofen 600 mg tablets due to odor complaints linked to CGMP deficiencies.
Time-Cap Laboratories is recalling specific lots of ibuprofen tablets due to odor complaints linked to CGMP deficiencies.
Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 600 mg due to odor complaints linked to CGMP deficiencies.
Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 400 mg due to odor complaints related to CGMP deficiencies.
Time-Cap Laboratories is recalling specific lots of Ibuprofen Caplets 200 mg due to odor complaints and CGMP deficiencies. The recall covers nationwide distribution.