FDA Drug recall D-0803-2016
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polar…
- FDA Drug
- Class II
- terminated
- Published 2016-04-13
On 2016-04-13 the FDA classified a Class II recall of Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polar… by Meditech Laboratories, citing lack of Assurance of Sterility: incomplete or missing data regarding production.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0803-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-14 |
| Published | 2016-04-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Meditech Laboratories |
| Distribution | US |
Product
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. .
Reason
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Identifiers
| code_info | Lot#: 022316-4, Exp 04/08/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0803-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.