Drug product
Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
D-0807-2016
Product summary
- Event
- Event 73537
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1320 vials - all formulas
- Official record key
drug-enforcement:D-0807-2016
Official wording
Reason: Lack of Assurance of Sterility: incomplete or missing data regarding production.
Code information: Lot#: 020716-0, Exp 05/07/16
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility