Recalls / Class II
Class IID-1138-2017
Product
Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g), Manufactured for Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-090-16
- Affected lot / code info
- Lot Number: A-K-8383
Why it was recalled
Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jelly. The boxes and outer case are correctly labeled as A&D ointment.
Recalling firm
- Firm
- MEDLINE INDUSTRIES INC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Lakes Dr, N/A, Northfield, Illinois 60093-2753
Distribution
- Quantity
- 462 cases, 144 packets per case
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-08-03
- FDA classified
- 2017-09-12
- Posted by FDA
- 2017-09-20
- Terminated
- 2017-11-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1138-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.