FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Methylphenidate Hydrochloride ER Capsules/Tablets
Status: Resolved
»Duration of Shortage: 09/23/2014 - 02/24/2016
»Therapeutic Categories: Pediatric; Psychiatry

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Actavis, Inc. (Revised 02/24/2016)

Company Contact Information:
800-272-5525

Presentation
  • Methylphenidate Hydrochloride, ER Capsules, 20 mg, 100s (NDC 67767-0200-01)
  • Methylphenidate Hydrochloride, ER Capsules, 30 mg, 100s (NDC 67767-0201-01)
  • Methylphenidate Hydrochloride, ER Capsules, 40 mg, 100s (NDC 67767-0202-01)
  • Methylphenidate Hydrochloride, ER Tablets, 18 MG 100s (NDC 00591-2715-01)
  • Methylphenidate Hydrochloride, ER Tablets, 27 MG 100s (NDC 00591-2716-01)
  • Methylphenidate Hydrochloride, ER Tablets, 36 MG 100s (NDC 00591-2717-01)
  • Methylphenidate Hydrochloride, ER Tablets, 54 MG 100s (NDC 00591-2718-01)
  • Methylphenidate HCL extended release tablets: 18 mg, 100-count (NDC 0591-2715-01); 27 mg, 100-count (NDC 0591-2716-01); 36 mg, 30-count (NDC 0591-2717-30); 36 mg, 100-count( NDC 0591-2717-01); 54 mg, 30-count (NDC 0591-2718-30); 54 mg, 100 count (NDC 0591-2718-01)
Note:
  • Available

Janssen Pharmaceuticals (Revised 02/24/2016)

Company Contact Information:
800-526-7736

Presentation
  • CONCERTA® Tablets: 36 mg, 100 count (NDC 50458-586-01)
  • CONCERTA® Tablets: 54 mg, 100 count (NDC 50458-587-01)
  • CONCERTA® Tablets: 18 mg, 100 count (NDC 50458-585-01)
  • CONCERTA® Tablets: 27 mg, 100 count (NDC 50458-588-01);
Note:
  • Available

Mallinckrodt (Revised 02/24/2016)

Company Contact Information:
800-325-8888

Presentation
  • 10 mg ER tablets 100 package size (NDC 00406-1445-01)
  • 20 mg ER tablets 100 package size (NDC 00406-1473-01)
  • 27 mg, 100 count bottle (NDC 0406-0127-01)
  • 36 mg, 100 count bottle (NDC 0406-0136-01)
  • 54 mg, 100 count bottle (NDC 0406-0154-01)
Note:
  • Available

Sandoz (Revised 02/24/2016)

Company Contact Information:
609-627-8500

Presentation
  • 20 mg Sustained-Release, 100s (NDC 00781-5754-01)
Note:
  • Inventory has now been depleted. The product will then be discontinued by Novartis and Sandoz.

Teva Pharmaceuticals (Revised 02/24/2016)

Company Contact Information:
800-545-8800

Presentation
  • 20mg, 100 count (NDC 0093-5346-01)
  • 30mg, 100 count (NDC 0093-5347-01)
  • 40mg, 100 count (NDC 0093-5348-01)
Note:
  • Teva has Methylphenidate ER Capsules on backorder and the company estimates a release date Q32016.

UCB Inc. (Revised 02/24/2016)

Company Contact Information:
800-477-7877

Presentation
  • METADATE CD (methylphenidate HCl, USP) Extended-Release Capsules 10 mg, 100s (NDC 53014-579-07)
  • Methylphenidate HCl Extended-Release Capsules CD 10 mg, 100sCD 10 mg, 100s (NDC 62175-151-37)
  • METADATE CD (methylphenidate HCl, USP) Extended-Release Capsules 30 mg, 100s (NDC 53014-581-07)
  • Methylphenidate HCl Extended-Release Capsules CD 30 mg, 100s (NDC 62175-153-37)
  • METADATE CD (methylphenidate HCl, USP) Extended-Release Capsules 40 mg, 100s (NDC 53014-582-07)
  • Methylphenidate HCl Extended-Release Capsules CD 40 mg, 100s (NDC 62175-154-37)
  • METADATE CD (methylphenidate HCl, USP) Extended-Release Capsules 50 mg, 100s (NDC 53014-583-07)
  • Methylphenidate HCl Extended-Release Capsules CD 50 mg, 100s (NDC 62175-155-37)
  • METADATE CD (methylphenidate HCl, USP) Extended-Release Capsules 60 mg, 100s (NDC 53014-584-07)
  • Methylphenidate HCl Extended-Release Capsules CD 60 mg, 100s (NDC 62175-156-37)
  • METADATE ER Tablets (methylphenidate hydrochloride extended-release tablets, USP), 20 mg Methylphenidate ER, 100s (NDC 53014-594-07)
  • METADATE CD (methylphenidate HCl, USP) Extended-Release Capsules, 20 mg, 100s (NDC 53014-580-07)
  • Methylphenidate HCl Extended-Release Capsules CD 20 mg, 100s (NDC 62175-152-37)
Note:
  • Available

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