Drug recall D-1055-2017

Class II Terminated reported Aug 9, 2017

Product

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

Reason for recall

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

Lots and codes

Lot #: HN7003

Recall details

Recalling firm
Time-Cap Laboratories, Inc., Farmingdale, NY
Quantity
1,980 bottles
Distribution
Nationwide U.S.A.
Type
Voluntary: Firm initiated
Recall initiated
June 16, 2017
Terminated
May 29, 2020

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