Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
Reported: June 1, 2016 Initiated: October 28, 2015 #D-0873-2016
Product Description
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
Reason for Recall
Defective Delivery System; potential to have inaccurate dosage delivery
Details
- Recalling Firm
- Sanofi-Aventis U.S. LLC
- Units Affected
- 159,000 prefilled injectors
- Distribution
- Nationwide
- Location
- Bridgewater, NJ
Frequently Asked Questions
What product was recalled? ▼
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company. Recalled by Sanofi-Aventis U.S. LLC. Units affected: 159,000 prefilled injectors.
Why was this product recalled? ▼
Defective Delivery System; potential to have inaccurate dosage delivery
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 1, 2016. Severity: Critical. Recall number: D-0873-2016.
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