Home / Recalls / Abbott's Compounding Pharmacy, Inc. / D-0707-2016

D-0707-2016 Class II Terminated

Recalled by Abbott's Compounding Pharmacy, Inc. — Berkeley, CA

Recall Details

Product Type
Drugs
Report Date
February 24, 2016
Initiation Date
January 15, 2016
Termination Date
April 6, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40 ml

Product Description

papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

Reason for Recall

Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.

Distribution Pattern

CA

Code Information

All lots

Other recalls by Abbott's Compounding Pharmacy, Inc.

  • D-0708-2016 Class II — papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, refr (January 15, 2016)
  • D-0718-2016 Class II — papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is Co (January 15, 2016)
  • D-0698-2016 Class II — papaverine phentolamine prostaglandin; 22.5/0.83 mg/8.3 mcg/mL; 5 mL and 10 mL u (January 15, 2016)
  • D-0688-2016 Class II — papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx i (January 15, 2016)
  • D-0676-2016 Class II — Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharmacy (January 15, 2016)
  • D-0686-2016 Class II — methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is Com (January 15, 2016)
  • D-0697-2016 Class II — papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, ref (January 15, 2016)
  • D-0715-2016 Class II — progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperat (January 15, 2016)
  • D-0692-2016 Class II — papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL unit (January 15, 2016)
  • D-0684-2016 Class II — Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Co (January 15, 2016)