Why it was recalled
Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
Product description
GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide and Puerto Rico
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-1353-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 20, 2016
- FDA report date
- Jul 20, 2016
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Murray International Trading Co., Inc.
Original FDA data
Every field from FDA enforcement report D-1353-2016, exactly as published.
Show all FDA fields
- City
- Brooklyn
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 74017
- Address
- 908 Dean St
- Code information
- All lots
- Postal code
- 11238-3204
- Report date
- Jul 20, 2016
- Product type
- Drugs
- Recall number
- D-1353-2016
- Classification
- Class II
- Recalling firm
- Murray International Trading Co., Inc.
- Product quantity
- Unknown
- Termination date
- Jun 14, 2018
- Reason for recall
- Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that bears drug/disease claims, making them unapproved drugs.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 20, 2016
- Initial firm notification
- Telephone
- Center classification date
- Jul 11, 2016