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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot Number: A-K-8383
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-1138-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 3, 2017
- FDA report date
- Sep 20, 2017
- Quantity
- 462 cases, 144 packets per case
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MEDLINE INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-1138-2017, exactly as published.
Show all FDA fields
- City
- Northfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77936
- Address
- 3 Lakes Dr
- Code information
- Lot Number: A-K-8383
- Postal code
- 60093-2753
- Report date
- Sep 20, 2017
- Product type
- Drugs
- Recall number
- D-1138-2017
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES INC
- Product quantity
- 462 cases, 144 packets per case
- Termination date
- Nov 21, 2017
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 3, 2017
- Initial firm notification
- Letter
- Center classification date
- Sep 12, 2017