CLASS II Drug recall · Reported 13 Apr 2016 · FDA Enforcement Report
Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg recalled
Meditech Laboratories is recalling Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL), distributed nationwide in the US. The recall was initiated on 14 Mar 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0805-2016
- FDA event ID
- 73537
- Recalling firm
- Meditech Laboratories, Las Vegas, NV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Mar 2016
- FDA classified
- 1 Apr 2016
- Reported
- 13 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Mar 2016 | Recall initiated by company | |
| 1 Apr 2016 | Classified by FDA | +18 days |
| 13 Apr 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Which lots are affected?
Lot#: 011916-1, Exp 04/19/16; 020316-1, Exp 05/03/16
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 73537This product is part of a recall event; the main page for the event is Formula 0 (PGE 20 mcg/mL) Injection vials recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Formula 0 (PGE 20 mcg/mL) Injection vials recalled | Meditech Laboratories | Sterility | Nationwide | |
| CLASS II | Formula 4 (Papaverine 18 mg, Phentolamine 2 mg recalled | Meditech Laboratories | Sterility | Nationwide | |
| CLASS II | Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg recalled | Meditech Laboratories | Sterility | Nationwide | |
| CLASS II | Formula 3 (Papaverine 20 mg, Phentolamine 3 mg recalled | Meditech Laboratories | Potency & Assay | Nationwide | |
| CLASS II | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg recalled | Meditech Laboratories | Potency & Assay | Nationwide | |
| CLASS II | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg recalled | Meditech Laboratories | Potency & Assay | Nationwide |
More recalls from Meditech Laboratories
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg recalled | Meditech Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Formula 2 (Papaverine 9 mg, Phentolamine 1 mg recalled | Meditech Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Formula 3 (Papaverine 20 mg, Phentolamine 3 mg recalled | Meditech Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg recalled | Meditech Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Formula 4 (Papaverine 18 mg, Phentolamine 2 mg recalled | Meditech Laboratories | Sterility | Nationwide |