The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0689-2018·Announced 2018-05-02

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 →

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