Reported Apr 13, 2016 · Terminated
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.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Meditech Laboratories, Inc · 3200 Polaris Ave Ste 27 · Las Vegas, NV · 89102-8379
Is this the product you have?
Formula 1 (Papaverine 1.8 mgPhentolamine 0.2 mgAtropine 0.02 mgPGE 18 mcg/mL) Injection5 mL vialRx onlyMeditech LaboratoriesInc3200 Polaris AveSuite 27Las VegasNV 89102
- Lot codes and dates
Lot#: 011916-1Exp 04/19/16020316-1Exp 05/03/16
- Amount recalled
- 1320 vials - all formulas
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
Why it was recalled
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
This product could cause temporary or reversible health problems — stop using it.
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