PlainRecalls
FDA Drug Moderate Class II Terminated

Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06

Reported: October 23, 2019 Initiated: September 12, 2019 #D-0141-2020

Product Description

Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06

Reason for Recall

CGMP Deviations: Received notice from supplier that there is potential glass contamination.

Details

Units Affected
29.1 grams
Distribution
Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.
Location
Gardena, CA

Frequently Asked Questions

What product was recalled?
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06. Recalled by Spectrum Laboratory Products. Units affected: 29.1 grams.
Why was this product recalled?
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 23, 2019. Severity: Moderate. Recall number: D-0141-2020.