Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27
Reported: May 13, 2020 Initiated: March 5, 2020 #D-1260-2020
Product Description
Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27
Reason for Recall
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 600 cartons/2 auto-injector per carton
- Distribution
- Product was distributed to 1 wholesaler who still had all units within their possession and had not shipped or further distributed any of the product.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27. Recalled by Teva Pharmaceuticals USA. Units affected: 600 cartons/2 auto-injector per carton.
Why was this product recalled? ▼
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 13, 2020. Severity: Moderate. Recall number: D-1260-2020.
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