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
- Recalling Firm
- Spectrum Laboratory Products
- 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.
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