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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: HN7003
Where it was sold
Nationwide U.S.A.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1055-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 16, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 1,980 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Time-Cap Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1055-2017, exactly as published.
Show all FDA fields
- City
- Farmingdale
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 77576
- Address
- 7 Michael Ave
- Code information
- Lot #: HN7003
- Postal code
- 11735-3921
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1055-2017
- Classification
- Class II
- Recalling firm
- Time-Cap Laboratories, Inc.
- Product quantity
- 1,980 bottles
- Termination date
- May 29, 2020
- Reason for recall
- Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide U.S.A.
- Recall initiation date
- Jun 16, 2017
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 3, 2017