Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
Time-Cap Laboratories is recalling various strengths of ibuprofen tablets due to odor complaints related to CGMP deficiencies.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves CGMP deficiencies related to odor complaints, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported serious injury.
Plain-English summary
Time-Cap Laboratories, Inc. is recalling various strengths of ibuprofen tablets and caplets. The recall is being conducted due to complaints of odor related to Current Good Manufacturing Practice (CGMP) deficiencies.
The affected products include Ibuprofen Tablets, USP, 200 mg, in various package sizes including 50, 100, 500, and 1000 tablets, as well as bulk bottles. The products were manufactured by Marksans Pharma, Ltd. in India and distributed nationwide.
Consumers who have purchased these products should stop using them and contact Time-Cap Laboratories for further instructions or a refund.
The recalled product
- Product
- IBUPROFEN (IBUPROFEN)
- Brand
- IBUPROFEN
- Manufacturer
- Time-Cap Laboratories, Inc.
- Category
- Drug — OTC Analgesic
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) D167C
- exp 2/18
- b) D172C
- H057C
- exp 6/18
- c) D164C
- E135C
- exp 3/18
- d) D172C
- F004C
- exp 5/18
- e) D175C
- D176C
- D177C
- D178C
- D179C
- D180C
- D162C
- D163C
- D164C
UPCs (5)
- 0349483600018
- 0349483601015
- 0349483600056
- 0349483114171
- 0349483600506
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Time-Cap Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
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See all →- ModerateTime-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
FDA (Drugs) · 2018-05-02
- ModerateIbuprofen Tablets Recalled Due to Odor Complaints and CGMP Deficiencies
FDA (Drugs) · 2018-05-02
- ModerateTime-Cap Recalls Ibuprofen Caplets Due to Odor Complaints and CGMP Deficiencies
FDA (Drugs) · 2018-05-02
- ModerateTime-Cap Recalls Ibuprofen Caplets Due to Odor Complaints
FDA (Drugs) · 2018-05-02
- ModerateTime-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
FDA (Drugs) · 2018-05-02
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