April 2012 Drug Information Update - Pharmacy Benefits ...

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Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=836 Source: www.ashp.org Amphetamine Mixed Salts, Extended-Release Capsules March 23, 2012 Products Affected - Description Amphetamine mixed salts extended-release capsules, Teva 5 mg capsules, 100 count (NDC 00555-0790-02) 10 mg capsules, 100 count (NDC 00555-0787-02) 15 mg capsules, 100 count (NDC 00555-0791-02) 20 mg capsules, 100 count (NDC 00555-0788-02) 25 mg capsules, 100 count (NDC 00555-0792-02) 30 mg capsules, 100 count (NDC 00555-0789-02) Amphetamine mixed salts extended-release capsules, Global Pharmaceuticals 5 mg capsules, 100 count (NDC 00115-1328-01) 10 mg capsules, 100 count (NDC 00115-1329-01) 15 mg capsules, 100 count (NDC 00115-1330-01) 20 mg capsules, 100 count (NDC 00115-1331-01) 25 mg capsules, 100 count (NDC 00115-1332-01) 30 mg capsules, 100 count (NDC 00115-1333-01) Reason for the Shortage • Teva cannot provide a reason for the shortage. • Global Pharmaceuticals states the shortage is due to increased demand. Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=577 Source: www.ashp.org Methotrexate Injection March 26, 2012 Products Affected - Description Methotrexate 25 mg/mL (with preservative), APP1 10 mL (with preservative) vial (NDC 63323-0123-10) 2 mL vial (NDC 63323-0123-02) – discontinued Methotrexate 25 mg/mL injection, Bedford2 2 mL vial, preservative-free (NDC 55390-0031-10) 4 mL vial, preservative-free (NDC 55390-0032-10) 8 mL vial, preservative-free (NDC 55390-0033-10) 10 mL vial, preservative-free (NDC 55390-0034-10) Methotrexate lyophilized powder for injection, Bedford2 1 gram vial (NDC 55390-0143-01) Methotrexate 25 mg/mL injection, Hospira3 2 mL (with preservative) vial (NDC 61703-0350-38) 40 mL preservative-free vial (NDC 61703-0408-41) Methotrexate 25 mg/mL injection, Mylan Institutional4 2 mL vial, preservative-free (NDC 10139-0062-02) 10 mL vial, preservative-free (NDC 10139-0062-10) 40 mL preservative-free vial (NDC 10139-0062-40) Methotrexate 25 mg/mL injection, Sandoz5 60
2 mL vial, preservative-free (NDC 66758-0040-02) 10 mL vial, preservative-free (NDC 66758-0040-08) 40 mL vial, preservative-free (NDC 66758-0041-01) Reason for the Shortage • APP has discontinued their methotrexate 25 mg/mL (with preservative) 2 mL vials. The 10 mL vials are on shortage due to increased demand for the product. FDA approved preservative-free methotrexate from APP in February, 2012. • Ben Venue voluntarily suspended all manufacturing and distribution in mid-November, 2011 on a temporary basis for maintenance and requalification of 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. • Hospira has methotrexate on shortage due to manufacturing delays. • Sandoz recalled their 2 mL and 10 mL methotrexate preservative-free vials in October, 2010. Sandoz cannot provide a reason for the current shortage. • Mylan Institutional (formerly Bioniche) cannot provide a reason for the shortage. • Bioniche was acquired by Mylan Institutional in September, 2011. Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=26 Source: www.ashp.org Azathioprine Injection March 26, 2012 Products Affected - Description Azathioprine injection, lyophilized powder, Bedford 100 mg vial (NDC 55390-0600-20) Reason for the Shortage • Ben Venue voluntarily suspended all manufacturing and distribution in mid-November, 2011 on a temporary basis for maintenance and requalification of 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 as the available products, listed on their website and are updating this information as it changes. • There are no other manufacturers of azathioprine injection. • The oral presentations are not affected by this shortage. Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=794 Source: www.ashp.org Protamine Sulfate March 27, 2012 Products Affected - Description Protamine Sulfate 10 mg/mL, American Pharmaceutical Partners (APP) 5 mL vials (NDC 63323-0229-05) 5 mL Novaplus vials (NDC 63323-0229-15) 25 mL vials (NDC 63323-0229-30) 25 mL Novaplus vials (NDC 63323-0229-35) Reason for the Shortage APP has protamine on shortage due to increased demand. There are no other manufacturers of protamine sulfate. 61
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April 2012 Drug Information Update
Page 3 and 4:
First-Time Generics GENERIC DRUG NA
Page 5 and 6:
GENERAL ANESTHETICS, INJECTABLE MID
Page 7 and 8:
Gruenhaupt, Mark R.Ph. Argus Health
Page 9 and 10: Statin Drugs - Drug Safety Communic
Page 11 and 12: Vytorin (ezetimibe/simvastatin) Tab
Page 13 and 14: low blood sugar (hypoglycemia) in p
Page 15 and 16: Some women with depression who beco
Page 17 and 18: Survival increased for all groups o
Page 19 and 20: finding that it also may reduce the
Page 21 and 22: Syringes (2 mL size), Rx only. NDC
Page 23 and 24: Patheon Pharmaceuticals Inc., Cinci
Page 25 and 26: 50-ct. bottles (NDC 0067-6238-50);
Page 27 and 28: PRODUCT (Class II) 1) Ventolin HFA
Page 29 and 30: Lot #: 0693, Exp: 10/2012 RECALLING
Page 31 and 32: 24 (Display case UPC# 3030045074923
Page 33 and 34: CODE Lot # 139961 RECALLING FIRM/MA
Page 35 and 36: Reason for the Shortage • Teva co
Page 37 and 38: Reason for the Shortage • Ben Ven
Page 39 and 40: Products Affected - Description Gan
Page 41 and 42: 37.5 mg/25 mg, 1000 count (NDC 0078
Page 43 and 44: Acyclovir tablets, Major 400 tablet
Page 45 and 46: 500 mg, 100 count (NDC 63304-0726-0
Page 47 and 48: 750 mg tablets, 100 count (NDC 1013
Page 49 and 50: • Bedford Laboratories has multip
Page 51 and 52: Daunorubicin Hydrochloride Injectio
Page 53 and 54: Ciprofloxacin Immediate-Release Tab
Page 55 and 56: • APP had tobramycin 40 mg/mL pre
Page 57 and 58: • Ben Venue voluntarily suspended
Page 59: 50 mg/mL, 10 mL vial, package of 10
Page 63 and 64: 5 mg single dose vial, package of 1
Page 65 and 66: 20 mL glass ampule, sterile pack (N
Page 67 and 68: 2 mL iSecure syringe (NDC 00406-112
Page 69 and 70: Lidocaine 0.5% Xylocaine 0.5% injec
Page 71 and 72: • Teva discontinued all ciproflox
Page 73 and 74: Nicardipine hydrochloride injection
Page 75 and 76: Article link: http://www.ashp.org/D
Page 77 and 78: • Apotex had metformin products u
Page 79: • Covis purchased all rights to F
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