FDAFDA · Food and drugs·Recall number D-0211-2018
Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47
Published January 17, 2018 · Recall initiated: December 15, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Akorn Inc
- Distributor
- Nationwide
- Lot
- Batch# 359774; Exp. 09/02/19
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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