Reported Apr 13, 2016 · Terminated
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.
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 9 (Papaverine 0.9 mgPhentolamine 0.1 mgAtropine 0.01 mgPGE 20 mcg/mL) Injection5 mL vialRx onlyMeditech LaboratoriesInc3200 Polaris AveSuite 27Las VegasNV 89102
- Lot codes and dates
Lot#: 022416-9Exp 04/09/16
- 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
Lack of Assurance of Sterility: incomplete or missing data regarding production.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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