Why it was recalled
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Product description
ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Lot numbers, UPCs & expiration codes
all lots
Where it was sold
U.S. Nationwide
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-0807-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 22, 2017
- FDA report date
- May 31, 2017
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0807-2017, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 76561
- Address
- 9265 Kirby Dr
- Code information
- all lots
- Postal code
- 77054-2520
- Report date
- May 31, 2017
- Product type
- Drugs
- Recall number
- D-0807-2017
- Classification
- Class II
- Recalling firm
- Advanced Pharma Inc.
- Termination date
- Oct 18, 2017
- Reason for recall
- Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ADD HEPARIN PF 50 Units ONLY TO TPN all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Feb 22, 2017
- Initial firm notification
- Center classification date
- May 23, 2017