Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 58 of 87
Mutual Pharmaceutical Company, Inc.
Class III Terminated
Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01
Reason: Chemical Contamination; benzophenone leached from the product label varnish
D-1423-2015 September 16, 2015 Philadelphia, PA
Healthpoint, Ltd
Class II Terminated
Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash in 1150 mL bottles. MARKETED BY: CafeFusion, Leawood, KS 66211, MANUFACTURED FOR: HEALTHPOINT, LTD Ft. W...
Reason: Chemical Contamination: Naphthalene compound identified in the product after complaints of a petroleum odor.
D-1427-2015 September 16, 2015 Fort Worth, TX
Mutual Pharmaceutical Company, Inc.
Class III Terminated
Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01
Reason: Chemical Contamination; benzophenone leached from the product label varnish
D-1420-2015 September 16, 2015 Philadelphia, PA
Mutual Pharmaceutical Company, Inc.
Class III Terminated
Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01
Reason: Chemical Contamination; benzophenone leached from the product label varnish
D-1425-2015 September 16, 2015 Philadelphia, PA
Mutual Pharmaceutical Company, Inc.
Class III Terminated
Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
Reason: Chemical Contamination; benzophenone leached from the product label varnish
D-1421-2015 September 16, 2015 Philadelphia, PA
3M Company - Health Care Business
Class II Terminated
DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w) Patient Preoperative Skin Preparation, supplied in a) 0.9 fl oz, 26 mL Single Use Applicator w/uret...
Reason: Chemical contamination: Product may be contaminated with a toxic compound.
D-1417-2015 September 16, 2015 Saint Paul, MN
Mutual Pharmaceutical Company, Inc.
Class III Terminated
Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01
Reason: Chemical Contamination; benzophenone leached from the product label varnish
D-1422-2015 September 16, 2015 Philadelphia, PA
South Coast Specialty Compounding, Inc.
Class II Terminated
Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1340-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1339-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1408-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1411-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1414-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1410-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1412-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1337-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1342-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1338-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1341-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1407-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1409-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1413-2015 September 9, 2015 Irvine, CA
South Coast Specialty Compounding, Inc.
Class II Terminated
Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA
Reason: Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
D-1415-2015 September 9, 2015 Irvine, CA
GlaxoSmithKline, LLC.
Class II Terminated
Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 00...
Reason: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
D-1360-2015 September 2, 2015 Zebulon, NC
GlaxoSmithKline, LLC.
Class II Terminated
Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Bo...
Reason: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
D-1362-2015 September 2, 2015 Zebulon, NC
GlaxoSmithKline, LLC.
Class II Terminated
Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSm...
Reason: Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
D-1361-2015 September 2, 2015 Zebulon, NC