The Recall Desk
ModerateFDA (Drugs)·D-0687-2018·Announced 2018-05-02

Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints and CGMP Deficiencies

Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 400 mg due to odor complaints related to Current Good Manufacturing Practice (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. The hazard involves odor complaints and CGMP deficiencies without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Time-Cap Laboratories, Inc. is recalling specific lots of Ibuprofen Tablets USP 400 mg. The affected products are prescription (Rx) bottles containing 100 tablets (NDC 49483-602-01) and 500 tablets (NDC 49483-602-50). The products were manufactured by Marksans Pharma, Ltd. in India and distributed nationwide.

The recall was initiated due to complaints regarding odor, which are attributed to Current Good Manufacturing Practice (CGMP) deficiencies. The source text does not report any illnesses or injuries associated with these products.

Consumers and healthcare providers should discontinue use of the affected lots and return them to the pharmacy or point of purchase. The specific lot codes and expiration dates for the recalled products are: M104C (exp 9/18), L016C (exp 9/18), H092C (exp 9/18), H093C (exp 9/18), C128C (exp 3/18), C129C (exp 3/18), C130C (exp 3/18), C132C (exp 3/18), and HK6011 (exp 7/18).

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 (13)

  • a) M104C
  • exp 9/18
  • L016C
  • H092C
  • and H093C
  • exp 9/18 b) C128C
  • C129C
  • C130C
  • C132C
  • exp 3/18
  • HK6011
  • exp 7/18
  • L016C and H092C

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 →

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