Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 13 of 87
Organics Corporation of America DBA Ambix Laboratories
Class II Ongoing
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for NaturesPlus 548 Broadhollow Road, Melville, NY 11747, USA
Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
D-0559-2022 February 23, 2022 Totowa, NJ
Revive Rx LLC dba Revive Rx Pharmacy
Class I Terminated
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.
Reason: Non-sterility; bacterial contamination identified as Paenibacillus lautus.
D-0648-2022 February 23, 2022 Houston, TX
Lohxa, LLC
Class I Terminated
SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24.
Reason: Microbial Contamination of Non-Sterile Product
D-0377-2022 January 26, 2022 Worcester, MA
Taro Pharmaceuticals U.S.A., Inc.
Class I Terminated
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532...
Reason: Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
D-0375-2022 January 19, 2022 Hawthorne, NY
Efficient Laboratories, Inc.
Class II Terminated
Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-275-06
Reason: Microbial Contamination of Non-Sterile Products
D-0291-2022 December 29, 2021 Miami, FL
Efficient Laboratories, Inc.
Class II Terminated
Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166, NDC 58593-235-06
Reason: Microbial Contamination of Non-Sterile Products
D-0290-2022 December 29, 2021 Miami, FL
Efficient Laboratories, Inc.
Class II Terminated
Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58593-829-04 and b) 6 Fl. Oz. (178 mL) bottles NDC 58593-829-06, Distributed by Efficient Laboratories, Inc. Miami, FL 33166
Reason: Microbial Contamination of Non-Sterile Products
D-0292-2022 December 29, 2021 Miami, FL
Efficient Laboratories, Inc.
Class II Terminated
Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166 UPC 0 00856 00309 5, NDC 58593-828-08
Reason: Microbial Contamination of Non-Sterile Products
D-0293-2022 December 29, 2021 Miami, FL
Bayer Healthcare Pharmaceuticals Inc.
Class I Terminated
LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-4140-2. UPC 3 11017 41031 8
Reason: Chemical Contamination: presence of benzene
D-0247-2022 November 24, 2021 Whippany, NJ
Bayer Healthcare Pharmaceuticals Inc.
Class I Terminated
Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 11017 41000 4, NDC 11523-4162-1, Product of Finland 20006105
Reason: Chemical Contamination: presence of benzene
D-0250-2022 November 24, 2021 Whippany, NJ
Bayer Healthcare Pharmaceuticals Inc.
Class I Terminated
Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a) Product of Ireland 86940418; (b)Product of Finland 20006106; Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product ...
Reason: Chemical Contamination: presence of benzene
D-0253-2022 November 24, 2021 Whippany, NJ
Bayer Healthcare Pharmaceuticals Inc.
Class I Terminated
LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
Reason: Chemical Contamination: presence of benzene
D-0246-2022 November 24, 2021 Whippany, NJ
Bayer Healthcare Pharmaceuticals Inc.
Class I Terminated
LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7
Reason: Chemical Contamination: presence of benzene
D-0248-2022 November 24, 2021 Whippany, NJ
Bayer Healthcare Pharmaceuticals Inc.
Class I Terminated
Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a) Product of Finland 20006101, (b) Product of Ireland 87022897, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, UPC 3 1...
Reason: Chemical Contamination: presence of benzene
D-0251-2022 November 24, 2021 Whippany, NJ
Bayer Healthcare Pharmaceuticals Inc.
Class I Terminated
Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 160g (5.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland, UPC 0 41100 58720 6, NDC 11523-0...
Reason: Chemical Contamination: presence of benzene
D-0249-2022 November 24, 2021 Whippany, NJ
Bayer Healthcare Pharmaceuticals Inc.
Class I Terminated
Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5
Reason: Chemical Contamination: presence of benzene
D-0252-2022 November 24, 2021 Whippany, NJ
Beiersdorf Inc
Class I Terminated
Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9
Reason: Chemical contamination; presence of benzene
D-0014-2022 October 27, 2021 Wilton, CT
Beiersdorf Inc
Class I Terminated
Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02870 1
Reason: Chemical contamination; presence of benzene
D-0013-2022 October 27, 2021 Wilton, CT
Beiersdorf Inc
Class I Terminated
Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02880 0
Reason: Chemical contamination; presence of benzene
D-0010-2022 October 27, 2021 Wilton, CT
Beiersdorf Inc
Class I Terminated
Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
Reason: Chemical contamination; presence of benzene
D-0012-2022 October 27, 2021 Wilton, CT
Beiersdorf Inc
Class I Terminated
Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02882 4
Reason: Chemical contamination; presence of benzene
D-0011-2022 October 27, 2021 Wilton, CT
Akorn, Inc.
Class II Terminated
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 1...
Reason: Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
D-0004-2022 October 13, 2021 Lake Forest, IL
Johnson & Johnson Consumer, Inc.
Class I Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distri...
Reason: Chemical Contamination: presence of benzene
D-0845-2021 October 6, 2021 Skillman, NJ
Johnson & Johnson Consumer, Inc.
Class I Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distrib...
Reason: Chemical Contamination: presence of benzene
D-0844-2021 October 6, 2021 Skillman, NJ
Jacobus Pharmaceutical Company Inc.
Class I Terminated
Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.
Reason: Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
D-0008-2022 October 6, 2021 Plainsboro, NJ