Dicopanol FusePaq Kit for Oral Suspension recall: Sterility Concern
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
Why was Dicopanol FusePaq Kit for Oral Suspension recalled?
Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.
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?
Lots: PL520, PL521, PL522 and PL523
- Product
- Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
- Recalling firm
- Fusion Pharmaceuticals, LLC
- Quantity
- 1,200 kits
- Distribution
- CA
- Recall date
- February 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)