Drug product
LIPO B STERILE INJECTION 10 mL ( Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine Hydrochloride 5 mg, Methylcobalamin 0.1mg, Benzyl Alcohol, Sterile Water, Sodium Hydroxide, Hydrochloric Acid), Multidose vial, Rx Only, Compounded by Eagle Pharmacy, Birmingham, AL 35244
D-1832-2015
Product summary
- Event
- Event 72101
- Status
- Terminated
- Classification
- Class II
- Quantity
- 104 vials
- Official record key
drug-enforcement:D-1832-2015
Official wording
Reason: Subpotent Drug: trace amounts of methylcobalamin in compounded drug.
Code information: Lot # 07072015LIPO; Exp. 12/15
Distribution pattern: TN, AL
Derived failure modes
-
Potency or specification failure
Subpotent