Formula 4 recall: Sterility Concern
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave.…
Why was Formula 4 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#: 022316-4, Exp 04/08/16
- Product
- Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave.…
- 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)