The Recall Desk
ModerateFDA (Drugs)·D-1517-2014·Announced 2014-08-13

SST Corporation Recalls Tetrahydrozoline HCL Due to CGMP Deviations

SST Corporation is recalling Tetrahydrozoline HCL drums because they were stored in a non-GMP compliant warehouse in Italy.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation regarding storage conditions, which is a quality control issue rather than a direct contamination or mislabeling of a common allergen.

Plain-English summary

SST Corporation is recalling one 16 kg drum of Tetrahydrozoline HCL (NDC 12660-0048) manufactured by Societa Italiana Medicinali Scandicci (S.I.M.S.) in Italy. The specific lot number is 168.862, with an expiration date of 6/2017.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product was stored and dispensed in a warehouse at S.I.M.S. in Italy that was not compliant with GMP standards.

The product was distributed in California. Consumers and healthcare providers who possess this specific lot should stop using it and contact SST Corporation for further instructions.

The recalled product

Product
Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5
Manufacturer
SST Corporation
Category
Drug — Pharmaceutical Ingredient
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: 168.862
  • Expiry: 6/2017

Distribution

Distributed in 1 state:

Related recalls

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