Papav/Phentol/PG E1 recall: Sterility Concern
Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
Why was Papav/Phentol/PG E1 recalled?
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: t07312013@20, t09162013@43, t08282013@18, t08292013@11
- Product
- Papav/Phentol/PG E1, 30 mg/1 mg/20 mcg/mL, injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Recalling firm
- Specialty Medicine Compounding Pharmacy
- Quantity
- 35.5 mL
- Distribution
- Hospitals, clinics, physicians, and patients in the Michigan area only.
- Recall date
- January 22, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)