Home / Recalls / Meditech Laboratories, Inc / D-0804-2016

D-0804-2016 Class II Terminated

Recalled by Meditech Laboratories, Inc — Las Vegas, NV

Recall Details

Product Type
Drugs
Report Date
April 13, 2016
Initiation Date
March 14, 2016
Termination Date
June 7, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1320 vials - all formulas

Product Description

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 Polaris Ave., Suite 27, Las Vegas, NV 89102.

Reason for Recall

Lack of Assurance of Sterility: incomplete or missing data regarding production.

Distribution Pattern

Nationwide

Code Information

Lot#: 022416-9, Exp 04/09/16.

Other recalls by Meditech Laboratories, Inc

  • D-0807-2016 Class II — Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, (March 14, 2016)
  • D-0802-2016 Class II — Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL) I (March 14, 2016)
  • D-0806-2016 Class II — Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) (March 14, 2016)
  • D-0803-2016 Class II — Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection, 5 (March 14, 2016)
  • D-0808-2016 Class II — Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), (March 14, 2016)
  • D-0805-2016 Class II — Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/ (March 14, 2016)