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.
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
Lot numbers, UPCs & expiration codes
Lot # 007F19AA, exp. date 04/2021
Where it was sold
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.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1260-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 5, 2020
- FDA report date
- May 13, 2020
- Quantity
- 600 cartons/2 auto-injector per carton
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-1260-2020, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85146
- Address
- 400 Interpace Pkwy
- Code information
- Lot # 007F19AA, exp. date 04/2021
- Postal code
- 07054-1120
- Report date
- May 13, 2020
- Product type
- Drugs
- Recall number
- D-1260-2020
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 600 cartons/2 auto-injector per carton
- Termination date
- Nov 19, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- 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.
- Recall initiation date
- Mar 5, 2020
- Initial firm notification
- Letter
- Center classification date
- May 5, 2020