FDAClass IIApril 13, 2016

Formula 2 recall: Superpotent

Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200…

Why was Formula 2 recalled?

Superpotent Drug: one ingredient was found to be above assay specification.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 110115-2, Exp 01/01/16

Product
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200…
Recalling firm
Meditech Laboratories, Inc
Quantity
1320 vials - all formulas
Distribution
Nationwide
Recall date
April 13, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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