D-1055-2017 Class II Terminated
FDA drug recall D-1055-2017 was initiated by Time-Cap Laboratories, Inc. on Jun 16, 2017 and is designated Class II. Reason for recall: Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg. The recall status is terminated (terminated May 29, 2020). Affected quantity: 1,980 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Aug 9, 2017
- Initiation Date
- Jun 16, 2017
- Termination Date
- May 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,980 bottles
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
Reason for recall
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Distribution pattern
Nationwide U.S.A.
Code information
Lot #: HN7003
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1055-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026