Recalls / Class II
Class IID-1260-2020
Product
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
- Brand name
- Epinephrine
- Generic name
- Epinephrine
- Active ingredient
- Epinephrine
- Route
- Intramuscular, Subcutaneous
- NDCs
- 0093-5985, 0093-5986
- FDA application
- ANDA090589
- Affected lot / code info
- Lot # 007F19AA, exp. date 04/2021
Why it was recalled
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 600 cartons/2 auto-injector per carton
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2020-03-05
- FDA classified
- 2020-05-05
- Posted by FDA
- 2020-05-13
- Terminated
- 2020-11-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1260-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.