Why it was recalled
Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium
Product description
Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808
Lot numbers, UPCs & expiration codes
Lot 204751 Exp. 04/15
Where it was sold
PA
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-0017-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 2, 2014
- FDA report date
- Oct 22, 2014
- Quantity
- 1,177 packets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unit Dose Solutions Inc
Original FDA data
Every field from FDA enforcement report D-0017-2015, exactly as published.
Show all FDA fields
- City
- Morrisville
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 68917
- Address
- 860 Aviation Pkwy Ste 400A
- Code information
- Lot 204751 Exp. 04/15
- Postal code
- 27560-7395
- Report date
- Oct 22, 2014
- Product type
- Drugs
- Recall number
- D-0017-2015
- Classification
- Class II
- Recalling firm
- Unit Dose Solutions Inc
- Product quantity
- 1,177 packets
- Termination date
- Oct 16, 2014
- Reason for recall
- Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808
- Distribution pattern
- PA
- Recall initiation date
- Jun 2, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 10, 2014