The Recall Desk
ModerateFDA (Drugs)·D-0690-2018·Announced 2018-05-02

Ibuprofen Tablets Recalled Due to Odor Complaints and CGMP Deficiencies

Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 600 mg 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 and involves CGMP deficiencies leading to odor complaints, which aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported serious injuries.

Plain-English summary

Time-Cap Laboratories, Inc. is recalling specific lots of Ibuprofen Tablets USP 600 mg. The affected products are distributed by Bi-Coastal Pharma International and manufactured by Marksans Pharma, Ltd. The recall covers 100-tablet bottles (NDC 42582-112-10) and 500-tablet bottles (NDC 42582-112-18).

The recall is being conducted due to complaints regarding odor, which are attributed to Current Good Manufacturing Practice (CGMP) deficiencies. The source text notes that various strengths of ibuprofen tablets and caplets are involved in this recall action.

The affected products were distributed nationwide. Consumers should check their medication for the specific lot codes and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or pharmacist for guidance.

The recalled product

Product
Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by: Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, In
Manufacturer
Time-Cap Laboratories, Inc.
Category
Drug — Prescription Medication
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 (10)

  • a) D044C
  • D038C
  • D043C
  • exp 3/18
  • b) C136C
  • D039C
  • D040C
  • D041C
  • D042C
  • 3/18

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 →

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