The Recall Desk
ModerateFDA (Drugs)·D-0691-2018·Announced 2018-05-02

Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints

Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 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 related to odor complaints 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 600 mg. The affected products are distributed by Drug Mart, Food Fair, in Medina, Ohio, and are available in 100-tablet and 500-tablet bottles. The recall covers lots C135C and C134C, both with an expiration date of 3/18.

The recall was initiated due to complaints regarding odor, which are related to Current Good Manufacturing Practice (CGMP) deficiencies. The agency has classified this as a Class II recall. The distribution pattern for these products is nationwide.

Consumers with these specific lots should stop using the product and contact their healthcare provider or pharmacist for guidance. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256
Manufacturer
Time-Cap Laboratories, Inc.
Category
Drug — 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 (3)

  • a) C135C
  • exp 3/18 b) C134C
  • 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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Same manufacturer · Time-Cap Laboratories, Inc.

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