Home / Recalls / Abbott's Compounding Pharmacy, Inc. / D-0676-2016

D-0676-2016 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: 7200 mL

Product Description

Bupivacaine, 0.25%, 450 mL, 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

Code Information

All lots

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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-0707-2016 Class II — papaverine phentolamine prostaglandin; 30/2 mg/20 mcg/mL; 5 mL and 10 mL unit (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-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)