Spectrum Laboratory Products Recalls Tetrahydrozoline Hydrochloride Due to CGMP Deviations
Spectrum Laboratory Products is recalling 16 bottles of Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle, due to storage in a non-GMP compliant warehouse.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 rather than a confirmed contamination or injury event.
Plain-English summary
Spectrum Laboratory Products is recalling 16 bottles of Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle (Cat. YY1568). The product is identified by Lot # 1BJ0479 and has an expiration date of 06/2017.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the product was stored and dispensed in a non-GMP compliant warehouse at S.I.M.S. in Italy.
The affected product was distributed in California. Consumers and healthcare providers should stop using the product and contact the recalling firm for further instructions.
The recalled product
- Product
- Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.
- Manufacturer
- Spectrum Laboratory Products
- Category
- Drug — Pharmaceutical Ingredient
- Affected units
- 16
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 #: 1BJ0479
- Expiry: 06/2017
Distribution
Distributed in 1 state:
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