Why it was recalled
Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Product description
Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50
Lot numbers, UPCs & expiration codes
Lot # 7700656A
Where it was sold
Product was distributed in Mason, OH.
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-0155-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 4, 2017
- FDA report date
- Jan 17, 2018
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Solco Healtcare US LLC
Original FDA data
Every field from FDA enforcement report D-0155-2018, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78697
- Address
- 2002 Eastpark Blvd Ste A
- Code information
- Lot # 7700656A
- Postal code
- 08512-3514
- Report date
- Jan 17, 2018
- Product type
- Drugs
- Recall number
- D-0155-2018
- Classification
- Class II
- Recalling firm
- Solco Healtcare US LLC
- Termination date
- Feb 25, 2019
- Reason for recall
- Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50
- Distribution pattern
- Product was distributed in Mason, OH.
- Recall initiation date
- Dec 4, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2018