Why it was recalled
Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
Product description
N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
Lot numbers, UPCs & expiration codes
Lot #: 86513, Exp 07/23/2014
Where it was sold
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-0011-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 18, 2014
- FDA report date
- Oct 15, 2014
- Quantity
- 3,529 Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unique Pharmaceutical, Ltd
Original FDA data
Every field from FDA enforcement report D-0011-2015, exactly as published.
Show all FDA fields
- City
- Temple
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 68841
- Address
- 5920 S General Bruce Dr
- Address (line 2)
- Ste 100
- Code information
- Lot #: 86513, Exp 07/23/2014
- Postal code
- 76502-5803
- Report date
- Oct 15, 2014
- Product type
- Drugs
- Recall number
- D-0011-2015
- Classification
- Class I
- Recalling firm
- Unique Pharmaceutical, Ltd
- Product quantity
- 3,529 Vials
- Termination date
- Feb 24, 2016
- Reason for recall
- Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 18, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 9, 2014