Formula 2 — Class II drug recall D-0808-2016
Terminated recall by Meditech Laboratories, Inc, reported 2016-04-13, distributed nationwide. Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyo
| Recall number | D-0808-2016 |
|---|---|
| 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 | labeling, specification failure |
| Lot numbers | 12216-2 |
| Expiration dates | 2016-04-22 |
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.
Reason for recall
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
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-0808-2016. 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.