FDAFDA · Food and drugs·Recall number 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.
Published April 13, 2016 · Recall initiated: March 14, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: incomplete or missing data regarding production.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Meditech Laboratories, Inc
- Distributor
- Nationwide
- Lot
- Lot#: 022416-9, Exp 04/09/16.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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