Why it was recalled
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Product description
Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
Lot numbers, UPCs & expiration codes
2005479, Exp 03/14
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-1326-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Feb 14, 2014
- FDA report date
- May 28, 2014
- Quantity
- 5,131 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ben Venue Laboratories Inc
Original FDA data
Every field from FDA enforcement report D-1326-2014, exactly as published.
Show all FDA fields
- City
- Bedford
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 67512
- Address
- 300 Northfield Rd
- Code information
- 2005479, Exp 03/14
- Postal code
- 44146
- Report date
- May 28, 2014
- Product type
- Drugs
- Recall number
- D-1326-2014
- Classification
- Class I
- Recalling firm
- Ben Venue Laboratories Inc
- Product quantity
- 5,131 vials
- Termination date
- Jun 29, 2015
- Reason for recall
- Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02
- Distribution pattern
- Nationwide.
- Recall initiation date
- Feb 14, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 19, 2014