Formula 9 — Class II drug recall D-0804-2016
Terminated recall by Meditech Laboratories, Inc, reported 2016-04-13, distributed nationwide. Lack of Assurance of Sterility: incomplete or missing data regarding production.
| Recall number | D-0804-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Meditech Laboratories, Inc, Las Vegas, NV, United States |
| Recall initiated | 2016-03-14 |
| Classified | 2016-04-01 |
| Reported by FDA | 2016-04-13 |
| Terminated | 2016-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 1,320 vials |
| Reason classes | sterility |
| Lot numbers | 022416-9 |
| Expiration dates | 2016-04-09 |
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.
Reason for recall
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0804-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.