Vancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling
Amneal Pharmaceuticals is recalling Vancomycin Hydrochloride Oral Solution nationwide due to manufacturing overfilling causing superpotency with higher-than-labeled concentration. The FDA classified this as Class I.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as Class I, the highest agency classification, which requires minimum severity score of 4 per the rubric. The hazard is overfilled product containing higher-than-labeled drug concentration, creating risk from elevated dosing.
Plain-English summary
Amneal Pharmaceuticals of New York, LLC is recalling Vancomycin Hydrochloride for Oral Solution, USP 250 mg per 5 mL, distributed nationwide in the United States. The affected product is packaged in 80 mL (NDC 69238-2261-3), 150 mL (NDC 69238-2261-7), and 300 mL (NDC 69238-2261-5) bottles, with approximately 821 bottles involved in the recall.
The product was recalled due to overfilling of drug powder during manufacturing, resulting in superpotent product containing a higher concentration of active ingredient than the labeled strength. The affected lot numbers are 22613003A, 22613004A, 22613005A, and 22613005B, all with an expiration date of September 30, 2025.
The FDA classified this as a Class I recall, indicating the highest level of hazard. Patients taking this medication expect dosing based on the labeled concentration of 250 mg per 5 mL; product with higher actual concentration than labeled creates a serious public health hazard.
The recalled product
- Product
- VANCOMYCIN HYDROCHLORIDE (VANCOMYCIN HYDROCHLORIDE)
- Brand
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Category
- Drug
- Affected units
- 821
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot # (a) 22613003A
- Exp. date 09/30/2025
- (b) 22613004A
- 22613005A
- (c) 22613005B
UPCs (3)
- 0369238226133
- 0369238226157
- 0369238226171
Distribution
Distributed nationwide across the United States.
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