Formula 9 recall: Sterility Concern
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…
Why was Formula 9 recalled?
Lack of Assurance of Sterility: incomplete or missing data regarding production.
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#: 022416-9, Exp 04/09/16.
- Product
- 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…
- 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)