Fentanyl Citrate USP recall: CGMP Deviations
Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
Why was Fentanyl Citrate USP recalled?
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 1HE0899, 1IB0005, Exp 02/28/2023
- Product
- Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
- Recalling firm
- Spectrum Laboratory Products
- Quantity
- 29.1 grams
- Distribution
- Product was distributed to compounding pharmacies and labs in CA, CO, MD, SC.
- Recall date
- October 23, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)