Drug & medication recalls Moderate risk

Time-Cap Laboratories, Inc. recalls Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Mic…

Recall date
June 16, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1055-2017
FDA classification
Class II
Brand / firm
Time-Cap Laboratories, Inc.
Sold / distributed
Nationwide U.S.A.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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