Drug product
HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162.
D-0050-2017
Product summary
- Event
- Event 73925
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1916 syringes
- Official record key
drug-enforcement:D-0050-2017
Official wording
Reason: Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Code information: Lot Numbers: 151200003M, 151260128M, 151300005M, 151310094M, 151320134M, 151320143M, 151340107M, 151370002M, 151390005M, 151390142M, 151400005M, 151400095M, 151400136M, 151470008M, 151510002M, 151520080M, 151880214M, 151890257M, Exp between 07/15/15-10/12/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
loss of potency