Drug product
Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
D-0804-2016
Product summary
- Event
- Event 73537
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1320 vials - all formulas
- Official record key
drug-enforcement:D-0804-2016
Official wording
Reason: Lack of Assurance of Sterility: incomplete or missing data regarding production.
Code information: Lot#: 022416-9, Exp 04/09/16.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility