The Recall Desk

FDA (Drugs) recall action 79349

Time-Cap Laboratories, Inc. recalled 11 products on 2018-05-02

The FDA (Drugs) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products
11
Announced
2018-05-02
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.

The agency’s own wording, quoted from the enforcement report.

1–11 of 11

  • ModerateFDA (Drugs)··2018-05-02

    Time-Cap Recalls Ibuprofen Tablets Due to Odor Complaints

    Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 400 mg due to odor complaints related to CGMP deficiencies.

    Product
    Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2018-05-02

    Ibuprofen Tablets Recalled Due to Odor Complaints and CGMP Deficiencies

    Time-Cap Laboratories is recalling specific lots of Ibuprofen Tablets USP 600 mg due to odor complaints linked to CGMP deficiencies.

    Product
    Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by: Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, In
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··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.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··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.

    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
    Category
    Distribution
    0 states