Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 54 of 87
GlaxoSmithKline, LLC
Class II Terminated
Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1525-44,
Reason: Penicillin Cross Contamination
D-1445-2016 July 27, 2016 Zebulon, NC
GlaxoSmithKline, LLC
Class II Terminated
Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.
Reason: Penicillin Cross Contamination
D-1444-2016 July 27, 2016 Zebulon, NC
Virtus Pharmaceuticals, Llc
Class III Terminated
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10
Reason: Chemical Contamination: Bottles may contain broken dessicants
D-1044-2016 June 29, 2016 Tampa, FL
Pacifico National, Inc. dba AmEx Pharmacy
Class I Terminated
Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Reason: Non-Sterility: Product tested positive for bacterial contamination.
D-0869-2016 June 1, 2016 Melbourne, FL
Pacifico National, Inc. dba AmEx Pharmacy
Class I Terminated
Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.
Reason: Non-Sterility: Product tested positive for bacterial contamination.
D-0870-2016 June 1, 2016 Melbourne, FL
Keystone Laboratories Inc
Class II Terminated
BETTER BRAIDS UN-BRAID (salicylic acid), Le Demelant, Packaged in 12 FL. OZ. (355 ml) Bottles, Over the Counter Only. Distributed by KEYSTONE LABORATORIES, UPC 07059600430.
Reason: Microbial Contamination of Non-Sterile Products: Failed S.aureus test.
D-0853-2016 May 25, 2016 Memphis, TN
Hospira Inc.
Class II Terminated
Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14
Reason: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
D-0832-2016 April 27, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2
Reason: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
D-0829-2016 April 27, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5
Reason: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
D-0830-2016 April 27, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5
Reason: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
D-0827-2016 April 27, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9
Reason: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
D-0828-2016 April 27, 2016 Lake Forest, IL
Hospira Inc.
Class II Terminated
Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2
Reason: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
D-0831-2016 April 27, 2016 Lake Forest, IL
Sagent Pharmaceuticals Inc
Class II Terminated
Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Single-Dose Container Bag, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, NDC 25021-0113-82
Reason: Cross contamination with other products: metronidazole
D-0780-2016 March 30, 2016 Schaumburg, IL
Keystone Laboratories Inc
Class II Terminated
Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ml.) bottle, Distributed by Keystone Laboratories, Memphis, TN 38101-2026, UPC 0 70596 00422 5.
Reason: Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result.
D-0726-2016 March 2, 2016 Memphis, TN
Fagron, Inc
Class II Terminated
SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx On...
Reason: Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
D-0655-2016 February 17, 2016 Saint Paul, MN
Fagron, Inc
Class II Terminated
SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Ma...
Reason: Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
D-0654-2016 February 17, 2016 Saint Paul, MN
Fagron, Inc
Class II Terminated
SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, ...
Reason: Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
D-0656-2016 February 17, 2016 Saint Paul, MN
Grato Holdings, Inc.
Class II Terminated
Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1, Dist. by Energique, Inc. Woodbine, IA 51579; ALSO LABELED AS --- Liddell La...
Reason: Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
D-0576-2016 January 27, 2016 Woodbine, IA
Grato Holdings, Inc.
Class II Terminated
Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin ...
Reason: Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
D-0575-2016 January 27, 2016 Woodbine, IA
Grato Holdings, Inc.
Class II Terminated
Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, First Aid Pa...
Reason: Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
D-0580-2016 January 27, 2016 Woodbine, IA
Grato Holdings, Inc.
Class II Terminated
Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laborato...
Reason: Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
D-0578-2016 January 27, 2016 Woodbine, IA
Grato Holdings, Inc.
Class II Terminated
Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories...
Reason: Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
D-0577-2016 January 27, 2016 Woodbine, IA
Grato Holdings, Inc.
Class II Terminated
Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Labo...
Reason: Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
D-0579-2016 January 27, 2016 Woodbine, IA
Freedom Pharmaceuticals Inc
Class II Terminated
Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (N...
Reason: Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
D-0567-2016 January 20, 2016 Broken Arrow, OK
Life Science Pharmacy Inc
Class II Terminated
ESTRIOL Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY
Reason: Penicillin Cross Contamination: potentially contaminated with penicillin
D-0489-2016 December 9, 2015 Harriman, NY