Why it was recalled
CGMP Deviations
Product description
Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402
Lot numbers, UPCs & expiration codes
Lot # A25593, Exp. 02/22/2017
Where it was sold
MA and NY
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-0905-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 7, 2016
- FDA report date
- Jun 21, 2017
- Quantity
- 1,933 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Safecor Health, LLC
Original FDA data
Every field from FDA enforcement report D-0905-2017, exactly as published.
Show all FDA fields
- City
- Woburn
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 74822
- Address
- 317 New Boston St
- Code information
- Lot # A25593, Exp. 02/22/2017
- Postal code
- 01801-6231
- Report date
- Jun 21, 2017
- Product type
- Drugs
- Recall number
- D-0905-2017
- Classification
- Class II
- Recalling firm
- Safecor Health, LLC
- Product quantity
- 1,933 bottles
- Termination date
- Jul 12, 2017
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Metronidazole 500mg Tablet, 50-count bottles, Rx only, Packaged By Safecor Health LLC Woburn, MA 01801, NDC 5011133402
- Distribution pattern
- MA and NY
- Recall initiation date
- Jul 7, 2016
- Initial firm notification
- Letter
- Center classification date
- Jun 12, 2017