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Class II: temporary or reversible health riskTerminated

Spectrum Laboratory Products Tetrahydrozoline Hydrochloride Recall

Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle

Spectrum Laboratory Products · Gardena, CA

Risk level
Class II
Reported by FDA
Nov 26, 2014
Recall ID
D-0255-2015
Check your lot numberHow we source this data

Summary

Spectrum Laboratory Products recalled Tetrahydrozoline Hydrochloride starting Jul 18, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0255-2015 on Nov 26, 2014. Reason: CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. Status: Terminated.

Why it was recalled

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

Product description

Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.

Lot numbers, UPCs & expiration codes

Lot #: 1BJ0479; Expiry: 06/2017

Where it was sold

U.S.: California.

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-0255-2015
Classification
Class II
Status
Terminated
Recall initiated
Jul 18, 2014
FDA report date
Nov 26, 2014
Quantity
16 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Spectrum Laboratory Products

Original FDA data

Every field from FDA enforcement report D-0255-2015, exactly as published.

Show all FDA fields
City
Gardena
State
CA
Status
Terminated
Country
United States
Event ID
69808
Address
14422 S San Pedro St
Code information
Lot #: 1BJ0479; Expiry: 06/2017
Postal code
90248-2027
Report date
Nov 26, 2014
Product type
Drugs
Recall number
D-0255-2015
Classification
Class II
Recalling firm
Spectrum Laboratory Products
Product quantity
16 Bottles
Termination date
Nov 24, 2014
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 Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.
Distribution pattern
U.S.: California.
Recall initiation date
Jul 18, 2014
Initial firm notification
Letter
Center classification date
Nov 20, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0255-2015, published Nov 26, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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