Recalls / Class III
Class IIID-0211-2018
Product
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
- Affected lot / code info
- Batch# 359774; Exp. 09/02/19
Why it was recalled
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Recalling firm
- Firm
- Akorn Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W Field Ct Ste 300, N/A, Lake Forest, Illinois 60045-4862
Distribution
- Quantity
- 4,885 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-12-15
- FDA classified
- 2018-01-08
- Posted by FDA
- 2018-01-17
- Terminated
- 2019-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0211-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.