Why it was recalled
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Product description
Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-230-57, barcode 0 69623 23057 7.
Lot numbers, UPCs & expiration codes
All lots remaining within expiry.
Where it was sold
Nationwide in the USA
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-1416-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 18, 2019
- FDA report date
- Jul 3, 2019
- Quantity
- 606 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Premier Pharmacy Labs Inc
Original FDA data
Every field from FDA enforcement report D-1416-2019, exactly as published.
Show all FDA fields
- City
- Weeki Wachee
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 83146
- Address
- 8265 Commercial Way
- Code information
- All lots remaining within expiry.
- Postal code
- 34613-4511
- Report date
- Jul 3, 2019
- Product type
- Drugs
- Recall number
- D-1416-2019
- Classification
- Class II
- Recalling firm
- Premier Pharmacy Labs Inc
- Product quantity
- 606 bags
- Termination date
- Oct 26, 2021
- Reason for recall
- Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-230-57, barcode 0 69623 23057 7.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 18, 2019
- Initial firm notification
- Press Release
- Center classification date
- Jun 21, 2019