February 2012 Drug Update Information - Pharmacy Benefits ...

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Labetalol Injection January 27, 2012 Products Affected - Description Labetalol injection 5 mg/mL, Akorn 40 mL vials (NDC 17478-0420-40) Labetalol injection 5 mg/mL, Bedford 20 mL vials (NDC 55390-0130-20) 40 mL vials (NDC 55390-0130-40) Labetalol injection 5 mg/mL, Hospira 4 mL Carpuject syringe (NDC 00409-2339-34) Labetalol injection 5 mg/mL, Sagent 20 mL vials (NDC 25021-0300-20) 40 mL vials (NDC 25021-0300-40) 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 multiple products affected by this temporary suspension of manufacturing. Bedford will have the affected, as well ass the available products, listed on their website and are updating this information as it changes. Hospira has labetaloll on shortage due to manufacturing delays. Sagent could not provide a reason for the shortage. Akorn states the reason for the shortage is demand exceeding supply. Apotex discontinued d their 4 mL vials (NDC 60505-0717-00) in February, 2010. The company could not provide a reason for the discontinuation. Article Link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=397 Source: http://www.a ashp.org Sodium Bicarbonate Injection January 27, 2012 Products Affected - Description Sodium Bicarbonate Injection 8.4%, Amphastar (IMS) 50 mL Min-I-Jet (NDC 00548-1052-00) - discontinued 50 mL Stick-Gard (NDC 00548-2052-00) - discontinued d Sodium Bicarbonate Injection 8.4%, American Regent 50 mL vial (NDC 00517-1550-25) - discontinued Sodium Bicarbonate Injection 7.5%, American Regent 50 mL vial (NDC 00517-0639-25) Sodium Bicarbonate Injection 4.2%, APP 5 mL vial (NDC 63323-0026-05) Sodium Bicarbonate Injection 4.2%, Hospira 10 mL syringe, 10 count (NDC 00409-5534- -34) Neut 4% sodium bicarbonate additive solution, Hospira 5 mL vial (NDC 00409-6609-02) Reason for the Shortage American Regent discontinued their sodium bicarbonate 8.4% 50 mL vials in 1st quarter, 2011. American Regent had temporarily suspendedd distributionn of most drug products including sodium bicarbonate. 38
American Regent resumed manufacturing in Shirley, New York in early-May, 2011. Hospira had sodium bicarbonate on back order due to manufacturing delays. Hospira discontinued d their sodium bicarbonate 8.4% 50 mL Ansyr syringes in August, 2009. APP has sodium bicarbonate on back order due to increased demand. Article Link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=7888 Source: http://www.a ashp.org Metoprolol Injection January 30, 2012 Products Affected - Description Metoprolol 1 mg/mL Injection, American Regent 5 mL vial, 25 count (NDC 00517-1355-25) Metoprolol 1 mg/mL Injection, APP 5 mL vial, 10 count (NDC 63323-0660-05) Metoprolol 1 mg/mL Injection, Bedford 5 mL vial, 10 count (NDC 55390-0073-10) 5 mL Novaplus vial, 10 count (NDC 55390-0348-10) Metoprolol 1 mg/mL Injection, Hospira 5 mL ampule, 12 count (NDC 00409-2285-05) 5 mL vial (NDC 00409-1778-05) Lopressor 1 mg/mL Injection, Novartis 5 mL ampule, 10 count (NDC 00078-0400-01) Metoprolol 1 mg/mL Injection, Sandoz 5 mL vial, 10 count (NDC 00781-3071-95) Reason for the Shortage American Regent had temporarily suspendedd manufacture of most drug products including metoprolol in April, 2011. American Regent resumed manufacturing in Shirley, New York in early-May, 2011. APP and Hospira state the shortage is due to increased demand for the product. 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. Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=813 Source: http://www.a ashp.org Methylphenidate Hydrochloride January 30, 2012 Products Affected - Description Extended-Release Presentations Methylin ER, Mallinckrodt 10 mg tablets, 100 count (NDC 00406-1423- -01) 20 mg tablets, 100 count (NDC 00406-1451- -01) Metadatee ER, UCB 20 mg tablets, 100 count (NDC 53014-0594- -07) Immediate Release Presentations s Methylin, Mallinckrodt 5 mg tablets, 100 count (NDC 00406-1121-01) 5 mg tablets, 1000 count (DC 00406-1121-10) 39
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: ecome unavailable for an extended t
Page 41 and 42: Trandate tablets, Prometheus 100 mg
Page 43 and 44: Article link: http://www.ashp.org/D
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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