The Recall Desk
ModerateFDA (Drugs)·D-0688-2018·Announced 2018-05-02

Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints

Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 400 mg 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 resulting in odor complaints, which aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported serious injury.

Plain-English summary

Time-Cap Laboratories, Inc. is recalling Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18). The affected product is distributed by Bi-Coastal Pharma International and manufactured by Marksans Pharma, Ltd. The recall is limited to lots with codes C128C and C129C, which have an expiration date of 3/18.

The recall was initiated due to complaints regarding the odor of the tablets, which are attributed to Current Good Manufacturing Practice (CGMP) deficiencies. The agency has classified this recall as Class II.

The product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific NDC and lot codes listed above. If the product is found, it should be returned to the distributor or recalled firm for further instructions.

The recalled product

Product
Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), 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, India
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 (3)

  • C128C
  • C129C
  • exp 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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