Drug product
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
D-0808-2016
Product summary
- Event
- Event 73537
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1320 vials - all formulas
- Official record key
drug-enforcement:D-0808-2016
Official wording
Reason: Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Code information: Lot #: 12216-2, Exp 04/22/16
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.