Drug Recalls

Central Admixture Pharmacy Services, Inc.

Class I Terminated

del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

Reason: Non Sterility; microbial contamination identified as Aspergillus species

D-1560-2014 September 3, 2014 Livonia, MI

Central Admixture Pharmacy Services, Inc.

Class I Terminated

adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

Reason: Non Sterility; microbial contamination identified as Aspergillus species

D-1561-2014 September 3, 2014 Livonia, MI

Central Admixture Pharmacy Services, Inc.

Class I Terminated

LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150

Reason: Non Sterility; microbial contamination identified as Aspergillus species

D-1562-2014 September 3, 2014 Livonia, MI

Pharmacy Creations

Class I Terminated

Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Pharmacy Creations, Randolph, NJ 07869.

Reason: Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold contamination.

D-1546-2014 August 27, 2014 Randolph, NJ

HLI dba Humphreyline Inc

Class II Terminated

Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel Cou...

Reason: Microbial Contamination of Non-Sterile Product

D-1518-2014 August 13, 2014 Florence, KY

Fagron, Inc

Class II Terminated

Fagron, Pentravan Plus Base 2.5 Kg, Article number: 804749. RX only, For prescription compounding, Oil-in-water emulsion base alternative to PLO gel, Added emulsifier ad viscosity-enhancing agent fo...

Reason: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

D-1498-2014 August 6, 2014 Saint Paul, MN

Fagron, Inc

Class II Terminated

Fagron, Pentravan Base 2.5 Kg, Article number: 802486. RX only, For prescription compounding, Oil-in-water emulsion, PLO gel alternative, Preserved and fragrance-free, Manufactured by; Fagron, Inc. ...

Reason: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

D-1497-2014 August 6, 2014 Saint Paul, MN

Fagron, Inc

Class II Terminated

Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant O...

Reason: Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.

D-1496-2014 August 6, 2014 Saint Paul, MN

Ferring Pharmaceuticals Inc

Class II Terminated

TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA ...

Reason: Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.

D-1385-2014 June 25, 2014 Parsippany, NJ

Fresenius Medical Care Holdings, Inc.

Class II Terminated

phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02

Reason: Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identifi...

D-1343-2014 May 28, 2014 Waltham, MA

SigmaPharm Laboratories LLC

Class II Terminated

Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa.

Reason: Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a pr...

D-1344-2014 May 28, 2014 Bensalem, PA

Mangiacotti

Class II Terminated

Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02...