Drug recall: Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech
Meditech Laboratories, Inc (Las Vegas, NV) initiated this drug recall on 14 Mar 2016; FDA lists 7 product records under event 73537, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 46% of the 288 drug enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 7 Jun 2016. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for Meditech Laboratories, Inc.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Meditech Laboratories, Inc, Las Vegas, NV.
Reason for recall
"Lack of Assurance of Sterility: incomplete or missing data regarding production."
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0802-2016 | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. | 1320 vials - all formulas | Class II | Terminated | 13 Apr 2016 |
| 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 Polaris Ave., Suite 27, Las Vegas, NV 89102. . | 1320 vials - all formulas | Class II | Terminated | 13 Apr 2016 |
| D-0804-2016 | 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. | 1320 vials - all formulas | Class II | Terminated | 13 Apr 2016 |
| D-0805-2016 | 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. | 1320 vials - all formulas | Class II | Terminated | 13 Apr 2016 |
| D-0806-2016 | Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. | 1320 vials - all formulas | Class II | Terminated | 13 Apr 2016 |
| D-0807-2016 | Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. | 1320 vials - all formulas | Class II | Terminated | 13 Apr 2016 |
| D-0808-2016 | 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. | 1320 vials - all formulas | Class II | Terminated | 13 Apr 2016 |
Context
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Lack of Assurance of Sterility: incomplete or missing data regarding production."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Jun 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.