Class II · Moderate risk
Myxredlin
CGMP Deviations
Insulin
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
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
Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Drug: Insulin Category: Diabetes Medication
- Recalling firm
- Abbott's Compounding Pharmacy, Inc.
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0684-2016 · 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 Insulin recalls
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Class II · Moderate risk
Sterile Diluent
CGMP Deviations
Class II · Moderate risk
Admelog
Lack of Assurance of Sterility: Malformed crimped collar seal
Class I · High risk
Insulin Glargine
Labeling: Missing label: Label missing from some prefilled pens.
Class I · High risk
Insulin Glargine
Labeling: Missing label on the vial
Other recalls by Abbott's Compounding Pharmacy, Inc.
All 2016 recalls
Class II · Moderate risk
papaverine phent
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.
Class II · Moderate risk
testosterone cypionate
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.
Class II · Moderate risk
testosterone cypionate
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.
Class II · Moderate risk
progesterone/testosterone
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.
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