Why it was recalled
CGMP Deviations
Product description
Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
Lot numbers, UPCs & expiration codes
Lots: 061496A, Exp. 06/2018; 111696A, Exp. 11/2018; 061947A, Exp. 06/2019; 091267A, Exp. 09/2019
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-0916-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 22, 2018
- FDA report date
- Jul 18, 2018
- Quantity
- 89,507 vials
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0916-2018, exactly as published.
Show all FDA fields
- City
- Decatur
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80310
- Address
- 1222 W Grand Ave
- Code information
- Lots: 061496A, Exp. 06/2018; 111696A, Exp. 11/2018; 061947A, Exp. 06/2019; 091267A, Exp. 09/2019
- Postal code
- 62522-1412
- Report date
- Jul 18, 2018
- Product type
- Drugs
- Recall number
- D-0916-2018
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Product quantity
- 89,507 vials
- Termination date
- Nov 6, 2020
- Reason for recall
- CGMP Deviations
- Product description
- Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Jun 22, 2018
- Center classification date
- Jul 9, 2018