hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Reported: February 24, 2016 Initiated: January 15, 2016 #D-0682-2016
Product Description
hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, 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.
Details
- Recalling Firm
- Abbott's Compounding Pharmacy, Inc.
- Units Affected
- 38 ml
- Distribution
- CA
- Location
- Berkeley, CA
Frequently Asked Questions
What product was recalled? ▼
hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705. Recalled by Abbott's Compounding Pharmacy, Inc.. Units affected: 38 ml.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 24, 2016. Severity: Moderate. Recall number: D-0682-2016.
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