Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 53 of 87
Claris Lifesciences Inc
Class II Terminated
Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, N...
Reason: Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
D-0613-2017 April 5, 2017 North Brunswick, NJ
Mylan Pharmaceuticals Inc.
Class II Terminated
Atorvastatin Calcium Tablets, 40 mg*, packaged in a) 90-count bottles (NDC 0378-3952-09) and b) 500-count bottles (NDC 0378-3952-07); Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
D-0620-2017 April 5, 2017 Morgantown, WV
Claris Lifesciences Inc
Class II Terminated
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 3600...
Reason: Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
D-0615-2017 April 5, 2017 North Brunswick, NJ
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Class II Terminated
Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.., NDC 51079-208-20
Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
D-0622-2017 April 5, 2017 Rockford, IL
Mylan Pharmaceuticals Inc.
Class II Terminated
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-3950-09); c) 500-count bottles (NDC 0378-3950-05); d) 500-count bottles (NDC 037...
Reason: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
D-0618-2017 April 5, 2017 Morgantown, WV
United Exchange Corporation
Class I Terminated
EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, NDC 0904-6491-20
Reason: Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
D-0496-2017 March 8, 2017 Cerritos, CA
L. Perrigo Company
Class II Terminated
Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only, Manufactured by Perrigo, Yeruham, Israel, Distributed by Perrigo, Allegan, MI --- NDC 45802-736-84, UPC 345802736840
Reason: Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of mold on the cap
D-0434-2017 January 25, 2017 Allegan, MI
Sage Products LLC
Class II Terminated
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over s...
Reason: CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
D-0230-2017 December 28, 2016 Cary, IL
Sage Products LLC
Class II Terminated
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC...
Reason: CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
D-0231-2017 December 28, 2016 Cary, IL
Sage Products LLC
Class I Terminated
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over s...
Reason: Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
D-0229-2017 December 28, 2016 Cary, IL
Town and Country Compounding and Consultation Services
Class I Terminated
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
Reason: Non-Sterility; microbial contamination identified as Bacillus circulans
D-0228-2017 December 28, 2016 Ridgewood, NJ
US Compounding Inc
Class I Terminated
Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
Reason: Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
D-0219-2017 December 28, 2016 Conway, AR
Cadila Pharmaceuticals Limited
Class II Terminated
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
Reason: Microbial Contamination of Non-Sterile Product
D-0164-2017 December 7, 2016 Ankleshwar
VistaPharm, Inc.
Class II Terminated
Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33...
Reason: Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
D-0146-2017 November 30, 2016 Largo, FL
The Harvard Drug Group
Class I Terminated
Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85
Reason: Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
D-0022-2017 October 19, 2016 Livonia, MI
B. Braun Medical Inc
Class I Terminated
5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
Reason: Non-Sterility: fungal contamination due to leaking containers.
D-0094-2017 October 19, 2016 Irvine, CA
Pharmatech LLC
Class II Terminated
Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1001-85.
Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
D-1524-2016 October 5, 2016 Davie, FL
Pharmatech LLC
Class II Terminated
Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL 33619, NDC 76518-100-08.
Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
D-1520-2016 October 5, 2016 Davie, FL
Pharmatech LLC
Class II Terminated
Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1000-59.
Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
D-1525-2016 October 5, 2016 Davie, FL
Pharmatech LLC
Class II Terminated
Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, N...
Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
D-1522-2016 October 5, 2016 Davie, FL
Pharmatech LLC
Class II Terminated
Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL 35243, NDC 23359-032-16.
Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
D-1521-2016 October 5, 2016 Davie, FL
Pharmatech LLC
Class II Terminated
Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0536-1025-47.
Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
D-1523-2016 October 5, 2016 Davie, FL
Pharmatech LLC
Class II Terminated
Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-6289-09.
Reason: CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
D-1526-2016 October 5, 2016 Davie, FL
GlaxoSmithKline, LLC
Class II Terminated
Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25,
Reason: Penicillin Cross Contamination
D-1443-2016 July 27, 2016 Zebulon, NC
GlaxoSmithKline, LLC
Class II Terminated
Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-22,
Reason: Penicillin Cross Contamination
D-1442-2016 July 27, 2016 Zebulon, NC