February 2012 Drug Update Information - Pharmacy Benefits ...

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Ranitidine Injectionn January 31, 2012 Products Affected - Description Ranitidine 25 mg/mL injection, Bedford 2 mL vial (NDC 55390-0616-10) 6 mL vial (NDC 55390-0616-01) 40 mL vial (NDC 55390-0618-01) Zantac 25 mg/mL injection, GlaxoSmithKline 2 mL vial (NDC 00173-0362-38) - discontinued 6 mL vial (NDC 00173-0363-01) - discontinued 40 mL vial (NDC 00173-0363-00) - discontinued Reason for the Shortage Ben Venue voluntarily suspendedd all manufacturing and distribution in mid-November, 2011 on a temporary basis for maintenance and requalification off equipment. Product will become available in stages as production resumes. Bedford Laboratories has temporarily suspended the distribution of Ben Venue Laboratories manufactured products. Availability of products is updated on the Bedford Laboratories website. GlaxoSmithKline sold Zantac injection to Covis Pharma a in late-December, 2012. Oral ranitidine products are not affected by this shortage. Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=820 Source: http://www.a ashp.org Oxymorphone Hydrochloride January 31, 2012 Products Affected - Description Extended-Release Presentations Opana ER, Endo 5 mg tablets, 100 count (NDC 63481-0907-70) 10 mg tablets, 100 count (NDC 63481-0674- -70) 20 mg tablets, 100 count (NDC 63481-0617- -70) 30 mg tablets, 100 count (NDC 63481-0571- -70) 40 mg tablets, 100 count (NDC 63481-0693- -70) Immediate-Release Presentations s Opana, Endo 5 mg tablets, 100 count (NDC 63481-0612-70) 10 mg tablets, 100 count (NDC 63481-0613- -70) Oxymorphone, Endo 5 mg tablets, 100 count (NDC 60951-0794-70) 10 mg tablets, 100 count (NDC 60951-0795- -70) Oxymorphone, Roxane 5 mg tablets, 100 count (NDC 00054-0283-25) 10 mg tablets, 100 count (NDC 00054-0284- -25) Reason for the Shortage Novartis voluntarily suspended all manufacturing and distribution from its Lincoln, Nebraska facility in early-January 2012 due to a potential for mixing of different products within a single bottle. Novartis plans to gradually resume manufacturingg at this facility after manufacturing improvements are implemented. Several Endo products that are manufactured at the Lincoln, Nebraska plant, are affected by this manufacturing suspension, including oxymorphone, Opana, and Opana ER. Roxane could not provide a reason for this shortage. 42
Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=882 Source: http://www.a ashp.org Nitazoxanide Tablets January 31, 2012 Products Affected - Description Alinia, Romark Laboratories 500 mg tablets, 30 count bottles (NDC 67546-0111-12) 500 mg tablets, 60 count bottles (NDC 67546-0111-11) 100 mg/5 mL powder for suspension, 60 mL bottle (NDC 67546-0212-21) Reason for the Shortage Romark states the reason for the shortage is manufacturin ng delay. Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=879 Source: http://www.a ashp.org Metoclopramide Injection January 31, 2012 Products Affected - Description Metoclopramide injection, Hospira 5 mg/mL, 2 mL vials (NDC 00409-341401) Reason for the Shortage Baxter had metoclopramide injection on back order due to regulatory issues. Baxter sold some generic injectable products to West-Ward. West-Ward then discontinued the metoclopramide injection in January, 2012. Teva discontinued metocloprami ide injectionn in February, 2011. Hospira discontinued d metoclopramide ampules in February, 2010, and Carpuject syringes in May, 2009. Hospira is the only manufacturer r of metoclopramide injection. Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=611 Source: http://www.a ashp.org Glycopyrrolate Injection January 31, 2012 Products Affected - Description Glycopyrrolate 0.2 mg/mL injection, West-Ward 1 mL vial (NDC 10019-0016-81) 2 mL vial (NDC 10019-0016-17) 5 mL vial (NDC 10019-0016-54) 20 mL vial (NDC 10019-0016-02) Robinul 0.2 mg/mL injection, West-Ward 1 mL vial (NDC 60977-0155-01) 2 mL vial (NDC 60977-0155-02) 5 mL vial (NDC 60977-0155-03) 20 mL vial (NDC 60977-0155-06) Reason for the Shortage West-Ward has acquired all Baxter Robinul and generic glycopyrrolate injectionn products. West- Ward cannot provide a reason for the shortage. American Regent had temporarily suspendedd manufacture of most drug products in April, 2011. American Regent resumed manufacturing in Shirley, New York in early-May, 2011. Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=385 Source: http://www.a ashp.org 43
Page 1 and 2: February 2012 Drug Information Upda
Page 3 and 4: GENERIC DRUG NAME GENERIC APPROVAL
Page 5 and 6: CICLOPIROX/ TOPICAL PEDIPIROX-4 New
Page 7 and 8: [Posted 01/09/2012] ISSUE: Novartis
Page 9 and 10: Studies Article Link: http://www.fd
Page 11 and 12: the use of XARELTO® (rivaroxaban),
Page 13 and 14: acteria. The Food and Drug Administ
Page 15 and 16: Statins raise risk of Type 2 diabet
Page 17 and 18: The Million Women Study, a U.K. pro
Page 19 and 20: Azithromycin 250 mg tablets, 1 card
Page 21 and 22: RECALLING FIRM/MANUFACTURE Recallin
Page 23 and 24: Recalling Firm: Pfizer Us Pharmaceu
Page 25 and 26: 250 mg, 100 count (NDC 00591-3969-0
Page 27 and 28: Sandoz states the shortage is due t
Page 29 and 30: 5 mL ampule (NDC 10019-0033-72) 20
Page 31 and 32: Article Link: http://www.ashp.org/D
Page 33 and 34: Lidocaine 2% (with epinephrine 1:10
Page 35 and 36: Source: http://www.a ashp.org Halop
Page 37 and 38: ecome unavailable for an extended t
Page 39 and 40: American Regent resumed manufacturi
Page 41: Trandate tablets, Prometheus 100 mg
Page 45 and 46: Bedford Laboratories has multiple p
Page 47 and 48: Thiothixene capsules, Mylan 2 mg ca
Page 49 and 50: 20 mL vials (NDC 10019-0905-03) - d
Page 51 and 52: 500 mg extended release, 500 count
Page 53 and 54: 1 mg/mL, 4 mL vial (NDC 25021-0781-
Page 55 and 56: West-Ward states the shortage is du
Page 57 and 58: 150 mL bottle (NDC 63304-0954-02) C

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