Class I · High risk
Papaverine HCl Injection
Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What 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. .
Drug: Papaverine
- Recalling firm
- Meditech Laboratories, Inc
- Origin
- NV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0803-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Papaverine recalls
See all
Class II · Moderate risk
TriMix Injection
Lack of Assurance of Sterility
Class II · Moderate risk
BiMix STD 001
Lack of Assurance of Sterility
Class II · Moderate risk
QuadMix Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
TriMix Plus 002
Lack of Assurance of Sterility
Other recalls by Meditech Laboratories, Inc
All 2016 recalls
Class II · Moderate risk
Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL)
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk
Formula 0 (PGE 20 mcg/mL)
Lack of Assurance of Sterility: incomplete or missing data regarding production.
Class II · Moderate risk
Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL)
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
Class II · Moderate risk
Formula 1
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
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