Lack of Assurance of Sterility
💊
Prescription Drugs
💊 Drugs • 12,141 recalls
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Distributed By: CDMA Inc., Novi, MI 48375, Made in China, NDC: 83698-675-30, UPC: 635515986718.
Xiamen Kang Zhongyuan Biotechnology Co.
Class I - Dangerous
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-count bag, Distributed By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL 34110, NDC: 83698-114-80, UPC: 383173000030.
Xiamen Kang Zhongyuan Biotechnology Co.
Class I - Dangerous
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Lack of Assurance of Sterility
QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flavor, 30-count bag, Distributed By: CDMA, Inc., Novi MI 48375, Made in China, NDC: 83698-616-25, UPC: 635515993372.
Xiamen Kang Zhongyuan Biotechnology Co.
Class I - Dangerous
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01
Fagron Compounding Services
Class I - Dangerous
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: use of an unapproved raw material
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: use of an unapproved raw material
Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01
Fagron Compounding Services
Class I - Dangerous
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class I - Dangerous
Lack of Assurance of Sterility
GE Healthcare Omnipaque (iohexol) Injection, 350 mg/mL (64.7%), Rx Only, Distributed by: GE Healthcare Inc., Marlborough, MA 01752 USA, NDC 0407-1414-91.
GE Healthcare Ireland Limited
Class I - Dangerous
Presence of particulate matter
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: use of an unapproved raw material
norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02
Fagron Compounding Services
Class I - Dangerous
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port