Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints
Time-Cap Laboratories is recalling specific lots of 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 deviations (odor) 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, 200 mg. The affected products are distributed by Drug Mart, Food Fair, in Medina, Ohio, and were distributed nationwide.
The recall was initiated due to complaints regarding odor, which are related to Current Good Manufacturing Practice (CGMP) deficiencies. The specific lots affected include NDC 53943-291-15 (50 tablets), NDC 53943-291-12 (100 tablets), and NDC 53943-291-14 (500 tablets).
Consumers should check their medication for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact their pharmacist or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- IBUPROFEN (IBUPROFEN)
- Brand
- IBUPROFEN
- Manufacturer
- Time-Cap Laboratories, Inc.
- Category
- Drug — OTC Analgesic
- 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 (6)
- a) D167C
- exp 2/18
- E135C
- exp 3/18
- b) D172C
- c) D167C
UPCs (1)
- 0093351027697
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 →Related recalls
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