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., Suite 27, Las Vegas, NV 89102. .
Reported: April 13, 2016 Initiated: March 14, 2016 #D-0803-2016
Product Description
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., Suite 27, Las Vegas, NV 89102. .
Reason for Recall
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Details
- Recalling Firm
- Meditech Laboratories, Inc
- Units Affected
- 1320 vials - all formulas
- Distribution
- Nationwide
- Location
- Las Vegas, NV
Frequently Asked Questions
What product was recalled? ▼
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., Suite 27, Las Vegas, NV 89102. .. Recalled by Meditech Laboratories, Inc. Units affected: 1320 vials - all formulas.
Why was this product recalled? ▼
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 13, 2016. Severity: Moderate. Recall number: D-0803-2016.
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