RecallRadar

FDA Drug recall D-1517-2014

Tetrahydrozoline HCL, 16 kg drum

On 2014-08-13 the FDA classified a Class II recall of Tetrahydrozoline HCL, 16 kg drum by Sst, citing CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1517-2014
ClassificationClass II
Statusterminated
Initiated2014-07-17
Published2014-08-13
Last updated2026-09-13 11:51 UTC
CompanySst
DistributionCA

Product

Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5

Reason

CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.

Identifiers

code_infoLot: 168.862, Expiry: 6/2017

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1517-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.