Why it was recalled
Labeling: Label Mix-Up
Product description
Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18
Lot numbers, UPCs & expiration codes
Lot #: R29364; Exp. 10/17
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-0800-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 10, 2016
- FDA report date
- Apr 6, 2016
- Quantity
- 63,636 plastic bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc
Original FDA data
Every field from FDA enforcement report D-0800-2016, exactly as published.
Show all FDA fields
- City
- Peapack
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 73285
- Address
- 100 North Route 206
- Code information
- Lot #: R29364; Exp. 10/17
- Postal code
- 07977
- Report date
- Apr 6, 2016
- Product type
- Drugs
- Recall number
- D-0800-2016
- Classification
- Class III
- Recalling firm
- Pfizer Inc
- Product quantity
- 63,636 plastic bottles
- Termination date
- Jun 22, 2016
- Reason for recall
- Labeling: Label Mix-Up
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 10, 2016
- Initial firm notification
- Telephone
- Center classification date
- Mar 31, 2016