FDAFDA · Food and drugs·Recall number 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.
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
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
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#: 011916-1, Exp 04/19/16; 020316-1, Exp 05/03/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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