Chart: FDA Recalls -- July 29, 2009

FDA Recalls		July 29, 2009
CLASS II
Fluocinonide Cream
USP 0.05%, (a) 15 gram (NDC 51672-1253-1) and (b) 120 gram (NDC 51672-1253-4), Rx only, packaged in aluminum tubes.
Manufacturer:	Taro Pharmaceuticals Inc., Brampton, Ontario, Canada.
Recalled by:	Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, by letter on May 26, 2009. Firm-initiated recall is ongoing.
Distribution:	Nationwide; (a) 928,617 units; (b) 36,278 units.
Reason:	Exceeded content uniformity specifications; 18-month stability.
Recall number:	D-1802-2009.
Nicomide Tablets
Nicotinamide, zinc, copper, folic acid. Each tablet contains Nicotinamide USP 750 mg, Zinc Oxide USP 25 mg, Cupric Oxide 1.5 mg and Folic Acid USP 500 mcg, 60 count bottles, Rx, NDC 65880-792-60.
Manufacturer:	Actavis Totowa LLC, Little Falls, NJ.
Recalled by:	Dusa Pharmaceuticals, Inc., Wilmington, MA, by fax and letter on April 8, 2009. Firm-initiated recall is ongoing.
Distribution:	Nationwide; 63,366 bottles.
Reason:	Failed dissolution specifications (zinc).
Recall number:	D-1803-2009.
Various Products Recalled by Advantage Dose
1) PROMETHAZINE, 25MG, Promethazine Suppositories, Mfg. G&W. Recall # D-1658-2009; 2) ONDANSETRON, ODT 4MG, Equiv: ZOFRAN 4MG ODT, Mfg. GPI. Recall # D-1659-2009; 3) POLYMYXIN B SULF VL INJECTION, 500MU, Mfg. BED, Recall # D-1660-2009; 4) DOCUSATE Na, 100MG, DOCUSATE SODIUM CAP, Mfg. IVX. Recall # D-1661-2009; 5) CLONIDINE Transderm. Patch, Catapres-TTS-2, 0.2mg/Day, Mfg. BOE, Recall # D-1662-2009; 6) CYCLOBENZAPRINE, 10MG, TABLET, Mfg. UDL. Recall # D-1663-2009; 7) NALTREXONE, sub: REVIA, 50MG TAB, Mfg EON, NDC 00185-0039-30. Recall # D-1664-2009; 8) TAMOXIFEN CIT, 10MG TAB, Mfg IVX. Recall # D-1665-2009; 9) GLEEVEC, IMATINIB MESYL., 100MG TAB, Mfg NVT. Recall # D-1666-2009; 10) NIASPAN E-R, NIACIN E-R, 500MG TABLET, Mfg KOS, NDC 60598-0140-01. Recall # D-1667-2009; 11) VERAPAMIL ER, 120MG CAP, Mfg MYL, NDC 00378-6320-01. Recall # D-1668-2009; 12) AVITENE 70X35 sheet, Mfg. MPI. Recall # D-1669-2009; 13) HYDROXYZINE HCl, sub: ATARAX, 25MG TABLET, Mfg VPI. Recall # D-1670-2009; 14) EPIVIR, LAMIVUDINE, 300MG TAB, Mfg. GSK. Recall # D-1671-2009; 15) HEPSERA, Adefovir Dipivoxil 10mg, 10MG TAB, Mfg. NEX. Recall # D-1672-2009; 16) COUMADIN INJ, WARFARIN, 5MG VIAL, Mfg. BRI. Recall # D-1673-2009; 18) DETROL, TOLTERODINE, 1MG TAB, Mfg. PFZ, Recall # D-1675-2009; 19) EFFEXOR, VENLAFAXINE, 75MG TAB, Mfg WYE, NDC 00008-0704-07. Recall # D-1676-2009; 20) KU-ZYME CAP, Mfg SWZ, NDC 00091-4122-01. Recall # D-1677-2009; 21) ELDEPRYL, SELEGILINE HCl, 5MG CAP, Mfg SOM, NDC 39506-0022-60. Recall # D-1678-2009; 22) PRIMAQUINE PHOSPHATE, 26.3MG (=15MG BASE), TAB, Mfg BAY. Recall # D-1679-2009; 23) PRIMIDONE, 250MG TABLET, Mfg QLT. Recall # D-1680-2009; 24) ANUCORT-HC, HYDROCORTISONE ACETATE, 25MG SUP, Mfg. G&W. Recall # D-1681-2009; 25) HECTOROL, DOXERCALCIFEROL, 2.5MG CAP, Mfg G/C, NDC 64894-0825-50. Recall # D-1682-2009; 26) BUPROPION, 150MG TABLET, Mfg. SDZ, NDC 00105-0415-01. Recall # D-1683-2009; 27) TERAZOSIN HCl, sub: HYTRIN, 2MG CAP, Mfg A-C, NDC 60505-0116-00. Recall # D-1684-2009; 28) PREDNISOLONE, 15MG/5ML SYRUP 5ML, Mfg. PMA, NDC 00121-0687-16. Recall # D-1685-2009; 31) IRON 47.5MG TAB, SLOW FE 47.5MG, Mfg. NVT, NDC 30083-0125-74. Recall # D-1688-2009; 33) ACETAMINOPHEN, PEDIATRIC, 120MG SUPPOSITORY, Mfg. GDL, NDC 00182-1662-11. Recall # D-1690-2009; 35) VITAMIN B-12, CYANOCOBALAMIN, 500MCG TAB, Mfg NVC, NDC 79854-0200-60. Recall # D-1692-2009; 43) CYCLOGYL 2%, CYCLOPENTOLATE, OPHTHALMIC SOLUTION, Mfg. ALC. Recall # D-1700-2009; 44) SYNTHROID, LEVOTHYROXINE SODIUM, 50MCG TAB, Mfg ABB, NDC 00074-04552-13. Recall # D-1701-2009; 45) OXCARBAZEPINE, 300MG TAB, Mfg BRK, NDC 51991-0293-01. Recall # D-1702-2009; 46) DOXAZOSIN MESYLATE, sub: CARDURA, 2MG TAB, Mfg ETH, NDC 58177-0267-04. Recall # D-1703-2009; 47) BETA-CAROTENE, 25000IU CAP, Mfg. NVC, NDC 79854-0100-11. Recall # D-1704-2009; 49) Dexfol, generic: Diatx, TAB, Mfg. RIS, NDC 64980-0128-09. Recall # D-1706-2009; 50) LODOSYN, CARBIDOPA, 25MG TAB, Mfg. BRI, NDC 00056-0511-68. Recall # D-1707-2009; 51) DILATRATE SR, ISOSORBIDE DN SR, 40MG CAP, Mfg SWZ, NDC 00091-0920-01. Recall # D-1708-2009; 52) AMITRIPTYLINE HCl, 25MG TAB, Mfg MYL, NDC 00378-2625-01. Recall # D-1709-2009; 53) LOTREL, AMLODIPINE/BENAZEPRIL, 5/10MG CAP, Mfg NVT, NDC 000-0405-05. Recall # D-1710-2009; 54) ONDANSETRON ODT, sub: ZOFRAN ODT, 8MG TAB, Mfg. GPI, NDC 68462-0158-13. Recall # D-1711-2009; 55) HYOSCYAMINE SUBLINGUAL, 0.125MG TAB, Mfg ETH, NDC 58177-0255-04. Recall # D-1712-2009; 56) DOXAZOSIN, DOXAZOSIN MESYLATE, 4MG TAB. Mfg A-C, NDC 60505-0095-00. Recall # D-1713-2009; 57) LOTENSIN, BENAZEPRIL HCL, 20MG TAB, Mfg. NVT, Recall # D-1714-2009; 58) NOREL DM, DM/CHLORPHEN/PHEN, 15/4/10MG/5ML, 5ML, Mfg. USP, NDC 52747-0410-00. Recall # D-1715-2009; 59) VENLAFAXINE HCL, 50MG TABLET, Mfg TEV, NDC 00093-7381-01. Recall # D-1716-2009; 60) DILT-XR, DILTIAZEM HCl ER, 240MG CAP, Mfg. A-C, NDC 60505-0016-06. Recall # D-1717-2009; 61) CASCARA SAGRADA, 50MG/15ML SYRUP, Qty 5ML, MFG: CYP, NDC 60258-0959-16. Recall # D-1718-2009; 62) METOPROLOL SUC ER, EXTENDED RELEASE, 50MG TAB, Mfg AZC, NDC 00186-7301-05. Recall # D-1719-2009; 63) HYDROXYZINE PAM, sub: VISTARIL, 25MG CAP, Mfg WAT, NDC 00591-0800-01. Recall # D-1720-2009; 65) TORSEMIDE, sub: DEMADEX, 5MG TAB, Mfg A-C, NDC 60505-0232-01. Recall # D-1722-2009; 66) DESIPRAMINE HCl, 100MG TAB, Mfg A/P. Recall # D-1723-2009; 67) HALOPERIDOL LACTATE, INJECTION, 5MG/ML VIAL, Mfg. GES. Recall # D-1724-2009; 68) PAROXETINE HCl, 10MG TAB, Mfg A-C, NDC 60505-0097-01. Recall # 1725-2009; 69)METHIMAZOLE, 5MG TAB, Mfg SDZ, NDC 00185-0205-01. Recall # D-1726-2009; 70) AMILORIDE/HCTZ, 5MG/50MG TAB, Mfg MYL, NDC 00378-0577-01. Recall # D-1727-2009; 78) ULTRASE MT18, PANCRELIPASE EC, CAP, Mfg. S/I. Recall # D-1735-2009; 79) CHOLINE MAG TRISALIC, 750MG TAB, Mfg. C-P. Recall # D-1736-2009; 80) NICOTINE POLACRILEX, 2MG GUM, Mfg. RUG. Recall # D-1737-2009; 81) MONOPRIL, FOSINOPRIL, 20MG TAB, Mfg BRI, NDC 00087-0609-42, Recall # D-1738-2009; 82) ERYTHROMYCIN, ERYTHROMYCIN BASE, 250MG TAB, Mfg ABB, NDC 00074-6326-13. Recall # D-1739-2009; 83) OMEPRAZOLE DR, 20MG CAP, Mfg RED, NDC 55111-0158-01. Recall # D-1740-2009; 84) FARESTON, TOREMIFENE CITRATE, 60MG TAB, Mfg GTX, NDC 11399-0005-30. Recall # D-1741-2009; 85) ATENOLOL, SUB: TENORMIN, 100MG TAB, Mfg SNZ, NDC 00781-1507-01. Recall # D-1742-2009; 86) FUROSEMIDE, sub: LASIX, 80MG TAB, Mfg MYL, NDC 00378-0232-01. Recall # D-1743-2009; 87) DILTIAZEM HCl, sub: CARDIZEM, 30MG TAB, Mfg MYL, NDC 00378-0023-01. Recall # D-1744-2009; 88) RIBAVIRIN, 200MG CAP, Mfg. MAL, NDC 004406-2260-84. Recall # D-1745-2009; 89) METOPROLOL/HCTZ, sub: Lopressor HCTZ, 50/25MG TAB, Mfg MYL, NDC 00378-0424-01. Recall # D-1746-2009; 90) BENAZEPRIL/HCTZ, 20/25MG TAB, Mfg SNZ, NDC 00185-0277-01. Recall # D-1747-2009; 91) ANAGRELIDE HCl, 1MG CAP, Mfg. MYL. Recall # D-1748-2009; 92) SOLU-CORTEF, HYDROCORTISONE Na SUC, 1000MG/8ML, INJECTION, Mfg. PFZ. Recall # D-1749-2009; 93) PERPHEN/AMITRIP, 4 MG-50 MG TABS, Mfg MYL, NDC 00378-0073-01. Recall # D-1750-2009; 94) GLYBURIDE/METFORM, sub: GLUCOVANCE, 1.25/250MG TAB, Mfg ACT, NDC 00228-2751-11. Recall # D-1751-2009; 95) FERROUS SULFATE ELIXIR, 220(44) MG/5ML, Qty 5ML, MFG: RUG, NDC 00536-0650-85. Recall # D-1752-2009; 96) ACYCLOVIR, 800MG TAB, Mfg TEV, NDC 00093-8947-01. Recall # D-1753-2009; 97) THYROID, 65MG (1GR) TAB, Mfg. MAJ, NDC 00904-0761-60. Recall # Recall # D-1754-2009; 98) ATENOLOL, 50MG TAB, Mfg SNZ, NDC 00781-1506-01, Recall # D-1755-2009; 99) ARAVA, LEFLUNOMIDE, 20MG TAB, Mfg AVE, NDC 00088-2161-30, Recall # D-1756-2009; 100) QUINAPRIL HCl, 40MG TAB, Mfg API, NDC 62037-0534-90, NDC 62037-0534-90. Recall # D-1757-2009; 101) DILTIAZEM, 60MG TAB, Mfg MYL, NDC 00378-0045-01. Recall # D-1758-2009; 102) LIDOCAINE/EPI-PHRINE, 2/0.001% VIAL 20ML, Mfg. MOS. Recall # D-1759-2009; 103) METRONIDAZOLE, 500MG TAB, Mfg PLV, NDC 50111-0334-01. Recall # D-1760-2009; 104) Metoprolol Tart, 100MG TAB, Mfg C-P, NDC 57664-0167-08. Recall # Recall # D-1761-2009; 105) THEO-24, THEOPHYLLINE E-R, 100MG CAP, Mfg UCB, NDC 50474-0100-01. Recall # D-1762-2009.
Manufacturer:	Advantage Dose LLC, Shreveport, LA.
Recalled by:	Manufacturer, by telephone, electronic mail, and letter beginning Nov. 26, 2008. Firm-initiated recall is ongoing.
Distribution:	AR, GA, IL, LA, MS, MO, OK, TX; 2,635,663 unit doses. (The volume is a total of all products recalled by Advantage Dose.)
Reason:	Not in conformance with cGMPs.
Recall numbers:	D-1658/1673, 1675/1685, 1688, 1690, 1692, 1699/1704, 1706/1720, 1722/1727 and 1735/1762-2009.
CLASS III
Elitek (Rasburicase)
For intravenous infusion, 7.5 mg/vial, packaged with diluent ampule, Rx only, NDC 0024-5151-75.
Manufacturer:	Sanofi-Aventis U.S. LLC, Saint Louis, MO.
Recalled by:	Sanofi-Aventis U.S. LLC, Bridgewater, NJ, by letters dated March 16, 2009. Firm-initiated recall is ongoing.
Distribution:	Nationwide; 887 cartons.
Reason:	The outer carton contained an incorrect expiration date. The inner components were correctly labeled.
Recall number:	D-1801-2009.
Leukine (Sargramostim)
1) 500 mcg/mL, multiple use vial, Rx only, NDC# 50419-050-99; 2) 5 x 500mcg/mL***liquid injection, contains preservative Sterile Rx only - 5 multiple use vials. NDC 50419-050-30; 3) 5 x 500mcg/mL***liquid injection, contains preservative Sterile Rx only - 5 multiple use vials. NDC 50419-050-30.
Manufacturer:	Hospira, Inc., Mc Pherson, KS.
Recalled by:	Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ, by letter on March 23, 2009. Firm-initiated recall is ongoing.
Distribution:	Nationwide; 48,960 vials.
Reason:	Product does not meet stability specification.
Recall numbers:	D-1763/1765-2009.
EDITORS' NOTE: Tabulation prepared from information provided by FDA. The agency has three classes of recalls. Class I - violative product poses reasonable probability of serious adverse health consequences or death; Class II - violative product may cause temporary or medically reversible adverse health consequences; probability of serious consequences remote; Class III - violative product not likely to cause adverse health consequences. Editors of "The Pink Sheet" appreciate hearing from any company that would like to provide additional information on any recall listed in a weekly tabulation.