Recalls / Class II
Class IID-0072-2017
Product
methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149.
- Affected lot / code info
- Lot Numbers: 15118069M, 15126004M, 151320095M, 15132023M, 15133005C, 15133011M, 15133032M, 15140003C, 15141005C, 15153010C, 151390098M, 15139065M, 15140074M, 151450122M, 15146010M, 15147052M, 15148046M, 15148058M, 15152062M,15160001C, 151680006C, 151720023M, 151720080M, 151730133M, 151740008C, 151740211M, 151800043C, 151880168M, Exp between 07/15/15-10/12/15
Why it was recalled
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
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
- 7556 syringes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-17
- FDA classified
- 2016-10-12
- Posted by FDA
- 2016-10-19
- Terminated
- 2017-06-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0072-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.