June 2017 FDA Recall Ibuprofen by Time-cap Laboratories, Inc.
D-1055-2017 - Presence of foreign tablets/capsules

This Class II drug recall was voluntarily initiated by Time-cap Laboratories, Inc. on June 16, 2017 for the product Ibuprofen. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1055-2017

Reason for Recall
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Initiated
06-16-2017
Reported
08-09-2017
Quantity
1,980 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77576
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Time-Cap Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide U.S.A.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-29-2020
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# : HN7003

Affected Packages Involved in this Recall

49483-602-01 Ibuprofen
49483-602-50 Ibuprofen
49483-603-03 Ibuprofen
49483-603-50 Ibuprofen
49483-603-05 Ibuprofen
49483-603-01 Ibuprofen
49483-604-01 Ibuprofen
49483-604-50 Ibuprofen
49483-604-05 Ibuprofen
49483-604-03 Ibuprofen