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 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Reported: April 13, 2016 Initiated: March 14, 2016 #D-0802-2016
Product Description
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 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Reason for Recall
Superpotent Drug: one ingredient was found to be above assay specification.
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 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 Polaris Ave., Suite 27, Las Vegas, NV 89102.. Recalled by Meditech Laboratories, Inc. Units affected: 1320 vials - all formulas.
Why was this product recalled? ▼
Superpotent Drug: one ingredient was found to be above assay specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 13, 2016. Severity: Moderate. Recall number: D-0802-2016.
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