FDA Drug Recalls

Recalls / Class III

Class IIID-0800-2016

Product

Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (237 mL), Distributed by Pfizer, Madison, NJ 07940, NDC 0031-8736-18

Affected lot / code info
Lot #: R29364; Exp. 10/17

Why it was recalled

Labeling: Label Mix-Up

Recalling firm

Firm
Pfizer Inc
Notification channel
Telephone
Type
Voluntary: Firm initiated
Address
100 North Route 206, N/A, Peapack, New Jersey 07977

Distribution

Quantity
63,636 plastic bottles
Distribution pattern
Nationwide

Timeline

Recall initiated
2016-02-10
FDA classified
2016-03-31
Posted by FDA
2016-04-06
Terminated
2016-06-22
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0800-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class III recall: drug · FDA Drug Recalls