Why it was recalled
Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
Product description
N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023
Lot numbers, UPCs & expiration codes
Lot 65323G20; Expiration: 7/22
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-0302-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 9, 2020
- FDA report date
- Nov 4, 2020
- Quantity
- 533 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jarrow Formulas Inc
Original FDA data
Every field from FDA enforcement report D-0302-2021, exactly as published.
Show all FDA fields
- City
- Los Angeles
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 86617
- Address
- 1824 S Robertson Blvd
- Code information
- Lot 65323G20; Expiration: 7/22
- Postal code
- 90035-4317
- Report date
- Nov 4, 2020
- Product type
- Drugs
- Recall number
- D-0302-2021
- Classification
- Class II
- Recalling firm
- Jarrow Formulas Inc
- Product quantity
- 533 units
- Termination date
- Apr 9, 2021
- Reason for recall
- Mislabeling of SUS (N-A-C Sustain 600 mg 100 tab) with N-A-C N-Acetyl-L-Cysteine 500 mg, 100 cap.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- N-A-C (N-Acetyl-L-Cysteine, 500 mg, 100 capsules; Veggie Caps, white HDPE bottle with RED label Product # 107002 UPC: 790011070023
- Distribution pattern
- Nationwide.
- Recall initiation date
- Oct 9, 2020
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 29, 2020