Why it was recalled
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Product description
Dexmedetomidine HCl all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Lot numbers, UPCs & expiration codes
all lots within expiry.
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-0846-2017
- 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-0846-2017, 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 within expiry.
- Postal code
- 77054-2520
- Report date
- May 31, 2017
- Product type
- Drugs
- Recall number
- D-0846-2017
- 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
- Dexmedetomidine HCl 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