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CLASS II
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Highly Concentrated Potassium Chloride Injection
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1). 400 mEq/L, 20 mEq, 50 mL, Ready to Use, Viaflex Plus Container, Rx Only, NDC 0338-0703-41. 2). 200 mEq/L, 20 mEq, 100 mL, Ready to Use, Viaflex Plus Container, Rx Only, NDC 0338-0705-48.
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Manufacturer:
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Baxter Healthcare Corp., Jayuya, PR.
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Recalled by:
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Baxter Healthcare Corp., Round Lake, IL. By letters dated Jun 8, 2011. Firm initiated recall is ongoing.
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Distribution:
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Nationwide, PR, Hong Kong, Singapore, Taiwan and Saudi Arabia, 705,730 Viaflex Plus Containers.
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Reason:
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Lack of Assurance of Sterility; Five lots and two sub-lots of Highly Concentrated Potassium Chloride Injection may not meet the bacterial endotoxin specifications due to an error in test interpretation and calculation. A Baxter investigation uncovered an error in the programming of analytical instrumentation and a subsequent misinterpretation of test data that could have resulted in those products not meeting the endotoxin specification. No adverse events have been reported and test results of the reserved batch samples met specifications. As a precautionary measure, Baxter is voluntarily recalling the affected product.
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Recall numbers:
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D-589/590-2011
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Ammonium Molybdate Injection
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USP, Molybdenum 250 meg/10 mL (25 meg/mL), 10 mL single dose vial, packaged in 25 x 10 mL single dose vials per tray pack, Rx Only; NDC 0517-6610-25, UPC3 05176 61025 2.
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Manufacturer:
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Luitpold Pharmaceuticals, Inc., Shirley, NY.
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Recalled by:
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Manufacturer; by press release and letters dated April 26, 2011. Firm initiated recall is ongoing.
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Distribution:
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Nationwide, 18,350 vials.
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Reason:
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Presence of Particulate Matter: Visual particulate matter was observed in retain and stability samples of Ammonium Molybdate Injection.
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Recall numbers:
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D-596-2011
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Nitrostat (Nitroglycerin) Tablets
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USP, 0.4mg, 1/150 gr, 4 bottles x 25 sublingual tablets, NDC # 0071-0418-13. 2) USP, 0.6mg 4 bottles X 25 sublingual tablets.
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Manufacturer:
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Pfizer Pharmaceuticals LLC, Vega Baja, PR
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Recalled by:
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Manufacturer, by telephone on May 18, 2011. Firm initiated recall is ongoing.
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Distribution:
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Nationwide and PR, 56,644 cartons.
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Reason:
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Adulterated Presence of Foreign Tablets: A bottle of Nitrostat 0.6 mg tablets, Lot # V100546, was discovered in a folding carton of Nitrostat 0.4 mg x 4 bottles/carton, Lot # V100670. Nitrostat 0.6mg Lot V100546 is not intended for sale in US market.
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Recall numbers:
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D-597/598-2011
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HydrALAzine Hydrochloride Tablets
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1) USP, 10 mg, a) 100-count bottle (NDC # 50111-398-01), b) 1,000-count bottle (NDC # 50111-398-03), Rx Only. 2) USP, 25 mg, a) 100-count bottle (NDC # 50111-327-01), b) 1,000-count bottle (NDC # 50111-327-03), Rx Only. 3) USP, 50 mg, a) 100-count bottle (NDC # 50111-328-01), b) 1000-count bottle (NDC # 50111-328-03), Rx Only. 4) USP, 100 mg, 100-count bottle, Rx Only, NDC 50111-397-01.
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Manufacturer:
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Pliva Krakow S.A., Krakow, Poland.
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Recalled by:
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Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on March 2, 2011, April 1, 2011 and on April 22, 2011. Firm initiated recall is ongoing.
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Distribution:
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Nationwide, PR, 70,432 bottles
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Reason:
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Tablet Thickness: Some tablets may not conform to weight requirements/specifications.
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Recall numbers:
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D-599/602-2011
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CLASS III
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Cortisporin Otic Solution Sterile
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(neomycin and polymyxin B sulfates and hydrocortisone otic solution, USP), 10 mL dropper bottle, Rx only; NDC# 61570-034-10.
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Manufacturer:
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DSM Pharmaceuticals Inc., Greenville, NC. Firm initiated recall is ongoing.
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Recalled by:
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King Pharmaceuticals a wholly owned subsidiary of Pfizer, Bristol, TN, by letter on May 26, 2011. Firm initiated recall is ongoing.
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Distribution:
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Nationwide, 24,031 dropper bottles
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Reason:
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Subpotency.
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Recall number:
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D-603-2011
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Prazosin HCl Capsules
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USP, 1 mg, 1000 count bottle, Rx only, NDC 0093-4067-10.
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Manufacturer:
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Teva Pharmaceuticals USA, Inc., Sellersville, PA,
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Recalled by:
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Manufacturer, by letter on April 11, 2011. Firm initiated recall is ongoing.
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Distribution:
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Nationwide, 4,487 bottles.
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Reason:
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Impurities/Degradation products.
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Recall number:
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D-614-2011
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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.
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