FDA Recalls Metronidazole Vaginal Gel Due to Manufacturing Temperature Abuse
The FDA is recalling Metronidazole Vaginal Gel USP 0.75% due to temperature abuse during manufacturing. The product was distributed nationwide in the United States.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The recall is for a manufacturing process deviation (temperature abuse) detected proactively without confirmed health impact, consistent with a precautionary recall.
Plain-English summary
The FDA is recalling Metronidazole Vaginal Gel USP 0.75% (NDC 0781-7077-87) distributed by McKesson Medical-Surgical Inc. The recall was initiated due to a current Good Manufacturing Practice (cGMP) deviation involving temperature abuse of the product during manufacturing.
This is a prescription medication used to treat bacterial infections. Seven tubes of the affected product were distributed nationwide in the United States. McKesson Medical-Surgical Inc. was unable to identify specific lot numbers in individual shipments to determine the exact units affected at each location.
Patients currently using this product should consult their healthcare provider or pharmacist regarding their medication. Do not stop taking the medication without first speaking with a healthcare professional. Individuals who have already used the recalled product and have questions or concerns should contact their pharmacist or physician.
The recalled product
- Product
- Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Vaginal
- Hazard
- temperature-abuse
- manufacturing-deviation
Distribution
Distributed nationwide across the United States.
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