Why it was recalled
Subpotent Drug
Product description
Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
Lot numbers, UPCs & expiration codes
Lot: 2021-10159 Exp. 06/08/2023
Where it was sold
AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VA
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-0852-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 2, 2021
- FDA report date
- Oct 6, 2021
- Quantity
- 14,976 FG cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- New Vision Pharmaceuticals LLC
Original FDA data
Every field from FDA enforcement report D-0852-2021, exactly as published.
Show all FDA fields
- City
- Tamarac
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 88608
- Address
- 10200 Nw 67th St
- Code information
- Lot: 2021-10159 Exp. 06/08/2023
- Postal code
- 33321-6404
- Report date
- Oct 6, 2021
- Product type
- Drugs
- Recall number
- D-0852-2021
- Classification
- Class III
- Recalling firm
- New Vision Pharmaceuticals LLC
- Product quantity
- 14,976 FG cartons
- Termination date
- Jun 21, 2023
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
- Distribution pattern
- AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI, SC, TN, TX, VA
- Recall initiation date
- Sep 2, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 24, 2021