The Recall Desk
ModerateFDA (Drugs)·D-0693-2018·Announced 2018-05-02

Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints

Time-Cap Laboratories is recalling specific lots of 800 mg ibuprofen 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 and involves CGMP deficiencies leading to odor complaints, which fits the criteria for moderate severity without reported serious injuries.

Plain-English summary

Time-Cap Laboratories, Inc. is recalling specific lots of Ibuprofen Tablets USP 800 mg. The affected products are distributed by Bi-Coastal Pharma International and manufactured by Marksans Pharma, Ltd. The recall includes 100-tablet and 500-tablet prescription bottles with specific lot codes and expiration dates of 2/18 and 3/18.

The recall was initiated due to complaints regarding odor, which are attributed to Current Good Manufacturing Practice (CGMP) deficiencies. The agency has classified this as a Class II recall. The products were distributed nationwide.

Consumers with these specific products should stop using them and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India
Manufacturer
Time-Cap Laboratories, Inc.
Category
Drug — Prescription Tablets
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 (12)

  • a) C140C
  • exp 2/18
  • b) D049C
  • D050C
  • D051C
  • C142C
  • C137C
  • C138C
  • C141C
  • D073C
  • D074C
  • 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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