Spectrum Chemical Recalls Fentanyl Citrate Due to Glass Contamination
Spectrum Laboratory Products is recalling Fentanyl Citrate USP active pharmaceutical ingredient due to potential glass contamination. The product was distributed to compounding pharmacies and labs in four states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pharmaceutical ingredient with a potential for physical injury (glass contamination) where no specific injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Spectrum Laboratory Products is recalling Fentanyl Citrate USP, an active pharmaceutical ingredient, due to potential glass contamination. The recall involves 29.1 grams of the product, identified by Lot # 1HE0899 and 1IB0005, with an expiration date of 02/28/2023.
The product was distributed to compounding pharmacies and laboratories in California, Colorado, Maryland, and South Carolina. The recall was initiated after the supplier notified the firm of the potential contamination.
Consumers and healthcare professionals should stop using the affected product and contact their supplier or the recalling firm for further instructions.
The recalled product
- Product
- Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
- Manufacturer
- Spectrum Laboratory Products
- Hazard
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 (3)
- Lot # 1HE0899
- 1IB0005
- Exp 02/28/2023
Distribution
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