Why it was recalled
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
Product description
SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.
Lot numbers, UPCs & expiration codes
Lot 0110701
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-0834-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 12, 2016
- FDA report date
- May 4, 2016
- Quantity
- 1,676 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Packaging Services
Original FDA data
Every field from FDA enforcement report D-0834-2016, exactly as published.
Show all FDA fields
- City
- Concord
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 73874
- Address
- 7101 Weddington Rd NW
- Code information
- Lot 0110701
- Postal code
- 28027-3412
- Report date
- May 4, 2016
- Product type
- Drugs
- Recall number
- D-0834-2016
- Classification
- Class III
- Recalling firm
- Mckesson Packaging Services
- Product quantity
- 1,676 boxes
- Termination date
- Mar 17, 2017
- Reason for recall
- Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 12, 2016
- Initial firm notification
- Letter
- Center classification date
- Apr 28, 2016