FDA-Drug2017-08-09Class II

Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50

Time-Cap Laboratories, Inc.
Hazard

Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.

Sold states
Nationwide U.S.A.
Affected count
1,980 bottles
Manufactured in
7 Michael Ave, N/A, Farmingdale, NY, United States
Products
Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Michael Avenue Farmingdale, NJ 11735, USA, Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate, Verna, Goa-403 722, India, NDC 49483-603-50

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1055-2017

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