Large Ibuprofen Recall Over Odor

Odor complaints have prompted Time Cap Labs to issue a nationwide recall for various strengths of ibuprofen tablets and caplets, according to the May 2, 2018, US Food and Drug Administration (FDA) Enforcement Report. 

The recalled drugs were manufactured by Marksans Pharma Ltd. and distributed across the country by Time-Cap Labs, Discount Drug Mart, and Bi-Coastal Pharma International.

The following strengths and counts manufactured for Time Cap Labs are being recalled: 

• 200-mg tablets in 
  • 50-count bottles (NDC 49483-601-05) from lot D167C (Exp. 2/18); 
  • 100-count bottles (NDC- 49483-601-01) from lots D172C (Exp. 2/18) and H057C (Exp. 6/18);
  • 500-count bottles (NDC 49483-601-50) from lots D164C (Exp. 2/18) and E135C (Exp. 3/18);
  • 1000-count bottles (NDC 49489-601-10) from lots D172C (Exp. 2/18), E135C (Exp. 3/18), and F004C (Exp. 5/18); and 
  • bulk bottles (NCD 49483-601-00) from lots D175C, D176C, D177C, D178C, D179C, D180C, D162C, D163C, D164C, D165C, D166C, D168C, D169C, D170C, D171C, D173C, E104C, E105C, D191C, D192C, D193C, D194C, D195C, D196C, D197C, D198C, D199C, D200C, D201C, and E106C (Exp. 2/18), L111C, F005C, F006C, F007C, F008C, H053C, H054C, H055C, and H056C (Exp. 5/18), L112C, L113C, L114C, L115C, L116C, L117C, L118C, L119C, J008C, J009C, H057C, and H058C (Exp. 6/18), and L120C, L121C, L122C, L123C, and L124C (Exp. 8/18).
• 400-mg prescription tablets in 
  • 100-count bottles (NDC 49483-602-01) from lots M104C (Exp. 9/18), L016C, H092C, and H093C (Exp. 9/18); and 
  • 500-count bottles (NDC 49483-602-50) from lots C128C, C129C, C130C, and C132C (Exp. 3/18), HK6011 (Exp. 7/18), and L016C and H092C (Exp. 9/18).
• 600-mg prescription tablets in 
  • 100-count bottles (NDC 49483-603-01) from lots C135C, D044C, D045C, and D038C (Exp. 3/18), F069C (Exp. 4/18), and H095C (Exp. 9/18), and
  • 500-count bottles (NDC 49483-603-50) from lots C134C, C136C, D039C, D040C, D041C, D042C, and D043C (Exp. 3/18), F043C, F067C, F068C, D046C, and D047C (Exp. 4/18), H094C (Exp. 7/18), and H096C, L026C, and H095C (Exp. 9/18).
• 800-mg prescription tablets in 
  • 100-count bottles (NDC 49483-604-01) from lots C139C and C140C (Exp. 2/18), and F044C (Exp. 8/18); and 
  • 500-count bottles (NDC 49483-604-50) from lots D048C, D049C, D050C, D051C, C142C, C137C, C138C, C139C, and C141C (Exp. 2/18), D052C, K207C, K208C, K209C, K210C, K211C, K212C, HM6122, HM6123, HM6124, HM6125, HM6126, K109C, K110C, K111C, HM6113, HM6114, HM6115, HM6116, HM6117, HM6118, F044C, H097C, H098C, H099C, H100C, H101C, K096C, K097C, K098C, K099C, K100C, K101C, and K102C (Exp. 8/18), and M105C, L017C, L018C, L019C, L020C, L021C, and L022C (Exp. 9/18). 
• 200-mg caplets in 50-count bottles (NDC 49483-600-05), 100-count bottles (NDC 49483-600-01), 500-count bottles (NDC 49483-600-50), and bulk bottles (NDC 49483-600-00) from lot F066C.

The following strengths and counts distributed by Discount Drug Mart are being recalled: 

• 200-mg tablets in 
  • 50-count bottles (NDC 53943-291-15) from lots D167C (Exp. 2/18) and E135C (Exp. 3/18);
  • 100-count bottles (NDC 53943-291-12) from lot D172C (Exp. 2/18); and
  • 500-count bottles (NDC 53943-291-14) from lot D167C (Exp. 2/18) and E135C (Exp. 3/18).
• 600-mg prescription tablets in 
  • 100-count bottles (NDC 42582-112-01) from lot C135C (Exp. 3/18); and
  • 500-count bottles (NDC 42582-112-18) from lot C134C (Exp. 3/18).
• 200-mg caplets in 50-count bottles (NDC 53943-292-15), 100-count bottles (NDC 53493-292-12), and 500-count bottles (NDC 53493-292-14) from lot F066C.

The following strengths and counts distributed by Bi-Coastal Pharma International are being recalled: 

• 400-mg prescription tablets in 500-count bottles (NDC 42582-111-18) from lots C128C and C129C (Exp. 3/18).
• 600-mg prescription tablets in
  • 100-count bottles (NDC 42582-112-10) from lots D044C, D038C, and D043C (Exp. 3/18); and
  • 500-count bottles (NDC 42582-112-18) from lots C136C (Exp. 3/18), D039C, D040C, D041C, and D042C (Exp. 3/18).
• 800-mg prescription tablets in
  • 100-count bottles (NDC 42582-113-10) from lot C140C (Exp. 2/18); and
  • 500-count bottles (NDC 42582-113-18) from lots D049C, D050C, D051C, C142C, C137C, C138C, and C141C (Exp. 2/18) and D073C and D074C (Exp. 3/18).

Time Cap Labs voluntarily initiated the recall January 11, 2018. On April 22, 2018, the FDA designated it Class II, signaling use of the medication could cause temporary or medically reversible harm, although the probability of serious adverse health consequences is remote.

Ibuprofen is a nonsteroidal anti-inflammatory drug used to relieve pain.

—Jolynn Tumolo

For more Pharmacy Learning Network articles, visit the homepage

To learn about Pharmacy Learning Network Live meetings, click here