Recalls / Class II
Class IID-1360-2016
Product
0.03% Bupivacaine HCl (Preservative Free) in Sodium Chloride 0.9%, 250 mL Medical Cassette Reservoir, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-931-11
- Affected lot / code info
- Lot # 160410097M; Exp. 05/16 Lot # 160420107M; Exp. 05/16 Lot # 160460117M; Exp. 05/16 Lot # 160530133M; Exp. 05/16 Lot # 160540206M; Exp. 05/16 Lot # 160570008M; Exp. 05/16 Lot # 160670132M; Exp. 06/16 Lot # 160700001C; Exp. 06/16 Lot # 160770020C; Exp. 06/16 Lot # 160900103C; Exp. 06/16
Why it was recalled
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Recalling firm
- Firm
- Pharmedium Services, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 150 N Field Dr Ste 350, N/A, Lake Forest, Illinois 60045-2506
Distribution
- Quantity
- 177 Medical Cassettes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-05-05
- FDA classified
- 2016-07-16
- Posted by FDA
- 2016-07-27
- Terminated
- 2018-03-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1360-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.