Drug product
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
D-0802-2016
Product summary
- Event
- Event 73537
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1320 vials - all formulas
- Official record key
drug-enforcement:D-0802-2016
Official wording
Reason: Superpotent Drug: one ingredient was found to be above assay specification.
Code information: Lot #: 110115-2, Exp 01/01/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Superpotent