Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
Time-Cap Laboratories is recalling specific lots of Ibuprofen 600 mg tablets due to odor complaints linked 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, but the specific hazard is odor complaints related to CGMP deficiencies without reports of serious injury or death, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
Time-Cap Laboratories, Inc. is recalling specific lots of Ibuprofen Tablets USP 600 mg. The recall affects 100-tablet and 500-tablet bottles (NDC 49483-603-01 and NDC 49483-603-50) manufactured by Marksans Pharma, Ltd. in India. The products were distributed nationwide.
The recall was initiated due to complaints regarding odor, which are attributed to Current Good Manufacturing Practice (CGMP) deficiencies. The FDA has classified this as a Class II recall.
Consumers with these specific products should stop using them and contact their healthcare provider or pharmacist for guidance. Specific lot codes and expiration dates are listed in the official recall notice.
The recalled product
- Product
- IBUPROFEN (IBUPROFEN)
- Brand
- IBUPROFEN
- Manufacturer
- Time-Cap Laboratories, Inc.
- Category
- Drug — Prescription Drug
- 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) C135C
- D044C
- D045C
- D038C
- exp 3/18
- F069C
- exp 4/18
- H095C
- exp 9/18 b) C134C
- C136C
- D039C
- D040C
- D041C
- D042C
- D043C
- F043C F067C
- F068C
- D046C
- D047C
- H094C
UPCs (6)
- 0349483604504
- 0349483604016
- 0349483602012
- 0349483602500
- 0349483603507
- 0349483603019
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
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- ModerateTime-Cap Recalls Ibuprofen Caplets Due to Odor Complaints
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- ModerateTime-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
FDA (Drugs) · 2018-05-02
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