Why it was recalled
Superpotent Drug: Due to overfilling of drug powder
Product description
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Lot numbers, UPCs & expiration codes
Lot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0442-2024
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Mar 21, 2024
- FDA report date
- Apr 24, 2024
- Quantity
- 821 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
Original FDA data
Every field from FDA enforcement report D-0442-2024, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 94262
- Address
- 50 Horseblock Rd
- Code information
- Lot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025
- Postal code
- 11719-9509
- Report date
- Apr 24, 2024
- Product type
- Drugs
- Recall number
- D-0442-2024
- Classification
- Class I
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Product quantity
- 821 bottles
- Termination date
- Jul 21, 2025
- Reason for recall
- Superpotent Drug: Due to overfilling of drug powder
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 21, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 12, 2024