Drug product
Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
D-0805-2016
Product summary
- Event
- Event 73537
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1320 vials - all formulas
- Official record key
drug-enforcement:D-0805-2016
Official wording
Reason: Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Code information: Lot#: 011916-1, Exp 04/19/16; 020316-1, Exp 05/03/16
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.