Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 20 of 87
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Class II Terminated
PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension Wes...
Reason: GMP Deviations: potential glass contamination
D-0149-2020 October 30, 2019 West Columbia, SC
Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center
Class II Terminated
PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extensi...
Reason: GMP Deviations: potential glass contamination
D-0148-2020 October 30, 2019 West Columbia, SC
Spectrum Laboratory Products
Class II Terminated
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Reason: CGMP Deviations: Received notice from supplier that there is potential glass contamination.
D-0141-2020 October 23, 2019 Gardena, CA
GCP Laboratories Inc
Class II Terminated
Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-589...
Reason: Microbial Contamination of Non-Sterile Product.
D-0126-2020 October 16, 2019 Gulfport, MS
Unipharma, Llc.
Class II Terminated
DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: ...
Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
D-0133-2020 October 16, 2019 Tamarac, FL
Unipharma, Llc.
Class II Terminated
DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 3332...
Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
D-0132-2020 October 16, 2019 Tamarac, FL
Johnson Matthey Inc.
Class II Terminated
Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX
Reason: cGMP Deviations: Potential glass contamination
D-1882-2019 October 2, 2019 West Deptford, NJ
Johnson Matthey Inc.
Class II Terminated
Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001.
Reason: cGMP Deviations: Potential glass contamination
D-1880-2019 October 2, 2019 West Deptford, NJ
Johnson Matthey Inc.
Class II Terminated
Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001
Reason: cGMP Deviations: Potential glass contamination
D-1881-2019 October 2, 2019 West Deptford, NJ
Ridge Properties, LLC
Class II Terminated
PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), and c) 4 OZ (NDC 69804-002-03) jars, OTC, Manufactured, packed ...
Reason: Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
D-1856-2019 September 25, 2019 Salem, OR
Ridge Properties, LLC
Class II Terminated
PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15), and c) 4 Oz (NDC 69804-019-16) bottles, OTC, Manufactured,...
Reason: Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
D-1857-2019 September 25, 2019 Salem, OR
Plastikon Healthcare LLC
Class I Terminated
Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals...
Reason: Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
D-1879-2019 September 18, 2019 Lawrence, KS
Pfizer Inc.
Class II Terminated
RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Irela...
Reason: Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.
D-1845-2019 September 4, 2019 New York, NY
Unipharma, Llc.
Class II Terminated
CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 ...
Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
D-1631-2019 August 14, 2019 Tamarac, FL
Unipharma, Llc.
Class II Terminated
CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0.05 fl. oz. (1.5 mL) each 1.5 fl. oz. (45 mL) total, Distributed by: CVS Pharmac...
Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
D-1633-2019 August 14, 2019 Tamarac, FL
Unipharma, Llc.
Class II Terminated
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33...
Reason: CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
D-1632-2019 August 14, 2019 Tamarac, FL
LNK International, Inc.
Class II Terminated
Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart Stores, Inc., Bentonville, AR 72716, NDC 49035-330-02, UPC 6 81...
Reason: Microbial contamination of non-sterile product
D-1630-2019 August 7, 2019 Hauppauge, NY
Geritrex, LLC
Class II Terminated
Ritussin DM Children & Adults, 4 Fl. Oz. (118 mL), RIJ Pharmaceutical Corporation 40 Commercial Avenue Middletown, NY 10941, NDC 53807-409-04
Reason: cGMP Deviations: Products may have microbial contamination.
D-1521-2019 July 31, 2019 Middletown, NY
Deva Holding AS - Cerkezkoy Subesi
Class II Terminated
Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07), b) 14-count bottle (NDC 67877-537-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turkey ...
Reason: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
D-1508-2019 July 31, 2019 Cerkezkoy, N/A
Geritrex, LLC
Class II Terminated
Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16
Reason: cGMP Deviations: Products may have microbial contamination.
D-1523-2019 July 31, 2019 Middletown, NY
Dercher Enterprises, Inc., DBA Gordon Laboratories
Class II Terminated
MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.
Reason: Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron conten...
D-1528-2019 July 31, 2019 Upper Darby, PA
Deva Holding AS - Cerkezkoy Subesi
Class II Terminated
Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-07), b) 14-count bottle (NDC 67877-541-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turke...
Reason: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
D-1512-2019 July 31, 2019 Cerkezkoy, N/A
Geritrex, LLC
Class II Terminated
Gericare Geri-Tussin DM, 16 FL OZ (473 mL), Geri-care Phamaceuticals Corp. 1650 63rd Street Brooklyn, NY, NDC 57896-660-16
Reason: cGMP Deviations: Products may have microbial contamination.
D-1526-2019 July 31, 2019 Middletown, NY
Bionpharma Inc.
Class II Terminated
Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45.
Reason: Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
D-1519-2019 July 31, 2019 Princeton, NJ
Deva Holding AS - Cerkezkoy Subesi
Class II Terminated
Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-07), b) 14-count bottle (NDC 67877-540-14), Rx only, Manufactured by: Deva Holding A.S., 1 Merkez Mahallesi, Istanbul, Turke...
Reason: CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
D-1511-2019 July 31, 2019 Cerkezkoy, N/A