Why it was recalled
Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
Product description
Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05
Lot numbers, UPCs & expiration codes
Lot # 12-2020-16@10, BUD 3-30-21 Lot # 11-2020-18@11, BUD 3-02-21
Where it was sold
Nationwide in the US
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-0306-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 17, 2021
- FDA report date
- Mar 24, 2021
- Quantity
- 213 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Edge Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0306-2021, exactly as published.
Show all FDA fields
- City
- Colchester
- State
- VT
- Status
- Terminated
- Country
- United States
- Event ID
- 87348
- Address
- 856 Hercules Dr
- Code information
- Lot # 12-2020-16@10, BUD 3-30-21 Lot # 11-2020-18@11, BUD 3-02-21
- Postal code
- 05446-8014
- Report date
- Mar 24, 2021
- Product type
- Drugs
- Recall number
- D-0306-2021
- Classification
- Class III
- Recalling firm
- Edge Pharma, LLC
- Product quantity
- 213 kits
- Termination date
- Jun 10, 2021
- Reason for recall
- Temperature Abuse; labeled with the incorrect room temperature (15-25 ¿C) storage conditions rather than the correct refrigerated (2 - 8 ¿C) storage conditions
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methacholine Challenge 5-Syringe Test Kits, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Dolchester, VT 06448 NDC # 05446-1600-05
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Feb 17, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 18, 2021