Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
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Other Drugs
💊 Drugs • 3,200 recalls
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
USCG Boat Response Kit - Product Code 80-0353, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Aid Backpack Kit - Product Code 85-0917, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Range Trauma Kit - Product Code 85-1274, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Amphibious Trauma Kit - Product Code 85-0639, North American Rescue
North American Rescue
Class I - Dangerous
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankleshwar, Gujarat, India 393002
Cadila Pharmaceuticals Limited
Class I - Dangerous
Microbial Contamination of Non-Sterile Product
Class I - Dangerous
Failed Stability Specifications; out-of specification value for homogeneity / phase separation.
Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01
GSK Consumer Healthcare
Class I - Dangerous
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Class I - Dangerous
Subpotent Drug: concentration of product is less than labeled amount.
lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441, NDC 61553-441-80
Pharmedium Services
Class I - Dangerous
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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
The Harvard Drug Group
Class I - Dangerous
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79
Pharmedium Services
Class I - Dangerous
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402
Pharmacy Plus, Inc.
Class I - Dangerous
Lack of Assurance of Sterility