Bulletin
Hydroxyzine Injection, Tablets, Capsules, and Syrup
06 October 2009
Products Affected - Description
Injection
Hydroxyzine hydrochloride solution for injection, APP
25 mg/mL, 1 mL vial (NDC 63323-0021-01) - discontinued
50 mg/mL, 1 mL vial (NDC 63323-0051-01) - discontinued
50 mg/mL, 2 mL vial (NDC 63323-0051-02) - discontinued
Tablets
Hydroxyzine hydrochloride tablets, Actavis - all presentations discontinued
Hydroxyzine hydrochloride tablets, Mutual - all presentations temporarily discontinued
Hydroxyzine hydrochloride tablets, Qualitest - all presentations discontinued
Hydroxyzine hydrochloride tablets, URL - all presentations temporarily discontinued
Syrup
Hydroxyzine hydrochloride syrup, Teva
10 mg/5mL syrup in 473 mL bottles (NDC 00182-1376-40) - discontinued
Reason for the Shortage
The raw material supplier for many of these companies was having manufacturing difficulties and is unable to supply hydroxyzine hydrochloride. Hydroxyzine pamoate capsules are available from Pfizer, Watson, Barr, UDL, and Eon.
Estimated Resupply Dates
Injection
- American Regent has available all hydroxyzine hydrochloride injections including the 25 mg/mL 1 mL vials (NDC 00517-4201-25), and 50 mg/mL 1 mL vials (NDC 00517-5601-25), 2 mL vials (NDC 00517-5602-25), and 10 mL vials (NDC 00517-5610-25).
- APP has discontinued all presentations of hydroxyzine hydrochloride injection.
Tablets
- Qualitest have temporarily discontinued their hydroxyzine hydrochloride products.
- Barr has all presentations available including the 10 mg tablets in 100 count (NDC 50111-0307-01), the 25 mg tablets in 100 count (NDC 50111-0308-01), the 25 mg in 1000 count (NDC 501110308-03), the 50 mg in 500 count (NDC 50111-0309-02) and 1000 count (NDC 50111-0309-03).
- URL, Mutual, UDL and Actavis have discontinued all presentations.
- Watson has all of their hydroxyzine hydrochloride presentations available including 10 mg tablets in 100 count (NDC 00591-5522-01) and 500 count (NDC 00591-5522-05) bottles and 25 mg tablets in 100 count (NDC 00591-5523-01), 500 count (NDC 00591-5523-05), and 1000 count (NDC 00591-5523-10) bottles.
Capsules
- Pfizer has available all of their Vistaril presentations including 25 mg capsules (NDC 00069-5410-66) and 50 mg capsules (NDC 00069-5420-66) in 100 count bottles.
- Barr has available all of their hydroxyzine pamoate 25 mg capsules in 100 (NDC 00555-0323-02) and 500 (NDC 00555-0323-04) count bottles, 50 mg capsules in 100 count (NDC 00555-0302-02) and 500 count (NDC 00555-0302-04) bottles, and 100 mg capsules in 100 count (NDC 00555-0324-02) bottles.
- UDL has available 25 mg unit-dose capsules (NDC 51079-0077-20) and 50 mg unit-dose capsules (NDC 51079-0078-20) in 100 count bottles.
- Watson has available all of their hydroxyzine pamoate presentations, including their 25 mg capsules in 100 (NDC 00591-0800-01) and 500 (NDC 00591-0800-05) count bottles, and 50 mg capsules in 100 (NDC 00591-0801-01) and 500 (NDC 00591-0801-05) count bottles.
- Eon has available all of their hydroxyzine pamoate presentations, including their 25 mg capsules in 100 (NDC 00185-0613-01) and 500 (NDC 00185-0613-05) count bottles, and 50 mg capsules in 100 (NDC 00185-0615-01) and 500 (NDC 00185-0615-05) count bottles.
Syrup
- Hi-Tech has available their hydroxyzine hydrochloride syrup in 473 mL bottles (NDC 50383-0796-16).
- Morton Grove has available both hydroxyzine hydrochloride presentations, including the 120 mL (NDC 60432-0150-04) and 480 mL (NDC 60432-0150-16) sizes.
- Teva discontinued their hydroxyzine hydrochloride syrup in 2008.
- Pfizer discontinued their hydroxyzine pamoate syrup
(Vistaril®) in July 2007.
Related Shortages
Updated
October 6, 2009; September 8, 2009; September 1, 2009; August 17, 2009; August 11, 2009; July 20, 2009; June 2, 2009; May 14, 2009; April 21, 2009; February 27, 2009; January 29, 2009; December 17, 2008; November 6, 2008; October 1, 2008; September 3, 2008; August 14, 2008; August 7, 2008; July 28, 2008; June 30, 2008; June 26, 2008; May 28, 2008; April 23, 2008; March 14, 2008, March 12, 2008, University of Utah, Drug Information Service. Copyright 2009, University of Utah, Drug Information Service.
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