Drug product
ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3348.
D-0056-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,173 syringes
- Official record key
drug-enforcement:D-0056-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 15117083M, 15117090M, 15118047M, 15121052M, 15124079M, 15126020M, 15127007M, 15127096M, 15133014M, 15133068M, 15134067M, 15139089M, 15140069M, 15141027M, 15141043M, 15142095M, 15146008M, 15149111M, 15149116M, 151730004M, 151730116M, 151880152M, 151890126M, 151930170M, 151940024M, 151940182M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency