Why it was recalled
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Product description
PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Lot numbers, UPCs & expiration codes
Lot:(a) 10102018@30, (b) 31102018@33,05112018@1, (c)15012019@8, (d) 30012019@33, distributed between 09-01-2018 to 02-20-2019.
Where it was sold
Dispensed in Oregon
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-1091-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 21, 2019
- FDA report date
- Apr 17, 2019
- Quantity
- 5 prescriptions 5,10, 6, 9 ml injectable
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-1091-2019, exactly as published.
Show all FDA fields
- City
- Corvallis
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 82278
- Address
- 996 Nw Circle Blvd Ste 105
- Code information
- Lot:(a) 10102018@30, (b) 31102018@33,05112018@1, (c)15012019@8, (d) 30012019@33, distributed between 09-01-2018 to 02-20-2019.
- Postal code
- 97330-1485
- Report date
- Apr 17, 2019
- Product type
- Drugs
- Recall number
- D-1091-2019
- Classification
- Class II
- Recalling firm
- Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
- Product quantity
- 5 prescriptions 5,10, 6, 9 ml injectable
- Termination date
- Jul 23, 2020
- Reason for recall
- Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
- Distribution pattern
- Dispensed in Oregon
- Recall initiation date
- Feb 21, 2019
- Initial firm notification
- Telephone
- Center classification date
- Apr 9, 2019