FDA Recall D-0093-2017
Pharmedium Services, LLC · Lake Forest, IL
Class I — life-threatening Terminated 707 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
Reason for recall
Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
Recall record
- Recall number
D-0093-2017- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide
- Recall initiated
- 2015-07-17
- Classified by FDA Center
- 2016-10-12
- FDA published
- 2016-10-19
- Terminated
- 2017-06-23
- Recalling firm
- Pharmedium Services, LLC
- Firm location
- Lake Forest, IL