Why it was recalled
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
Product description
Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5
Lot numbers, UPCs & expiration codes
Lot: 168.862, Expiry: 6/2017
Where it was sold
CA
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-1517-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 17, 2014
- FDA report date
- Aug 13, 2014
- Quantity
- 1 Drum
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SST Corporation
Original FDA data
Every field from FDA enforcement report D-1517-2014, exactly as published.
Show all FDA fields
- City
- Clifton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68891
- Address
- 635 Brighton Rd
- Code information
- Lot: 168.862, Expiry: 6/2017
- Postal code
- 07012-1027
- Report date
- Aug 13, 2014
- Product type
- Drugs
- Recall number
- D-1517-2014
- Classification
- Class II
- Recalling firm
- SST Corporation
- Product quantity
- 1 Drum
- Termination date
- Aug 4, 2016
- Reason for recall
- CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5
- Distribution pattern
- CA
- Recall initiation date
- Jul 17, 2014
- Initial firm notification
- Telephone
- Center classification date
- Aug 6, 2014