Recalls / Class II
Class IID-1055-2017
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
- Brand name
- Ibuprofen
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDCs
- 49483-602, 49483-603, 49483-604
- FDA application
- ANDA090796
- Affected lot / code info
- Lot #: HN7003
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.
Recalling firm
- Firm
- Time-Cap Laboratories, Inc.
- Manufacturer
- TIME CAP LABORATORIES, INC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 7 Michael Ave, N/A, Farmingdale, New York 11735-3921
Distribution
- Quantity
- 1,980 bottles
- Distribution pattern
- Nationwide U.S.A.
Timeline
- Recall initiated
- 2017-06-16
- FDA classified
- 2017-08-03
- Posted by FDA
- 2017-08-09
- Terminated
- 2020-05-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1055-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.