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
Reported: January 17, 2018 Initiated: December 15, 2017 #D-0211-2018
Product Description
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
Reason for Recall
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Details
- Recalling Firm
- Akorn Inc
- Units Affected
- 4,885 bottles
- Distribution
- Nationwide
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn Inc. Units affected: 4,885 bottles.
Why was this product recalled? ▼
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 17, 2018. Severity: Low. Recall number: D-0211-2018.
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