Why it was recalled
Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
Product description
Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
Lot numbers, UPCs & expiration codes
Lot # CFMBX, EXP 9/2022
Where it was sold
Distributed 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-0328-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 19, 2021
- FDA report date
- Apr 14, 2021
- Quantity
- 720 100-count (10x10 blister strips)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- X-Gen Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0328-2021, exactly as published.
Show all FDA fields
- City
- Horseheads
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 87500
- Address
- 300 Daniel Zenker Dr
- Code information
- Lot # CFMBX, EXP 9/2022
- Postal code
- 14845-1014
- Report date
- Apr 14, 2021
- Product type
- Drugs
- Recall number
- D-0328-2021
- Classification
- Class II
- Recalling firm
- X-Gen Pharmaceuticals Inc.
- Product quantity
- 720 100-count (10x10 blister strips)
- Termination date
- Dec 7, 2022
- Reason for recall
- Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Mar 19, 2021
- Initial firm notification
- Letter
- Center classification date
- Apr 8, 2021