Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77
Lot numbers, UPCs & expiration codes
Lot #GS009075; Exp. 09/17 Lot #GS009763; Exp. 09/17 Lot #GS010178; Exp. 10/17
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-0769-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 27, 2016
- FDA report date
- Mar 16, 2016
- Quantity
- 172 100-count packages (17,200 tablets)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Golden State Medical Supply Inc.
Original FDA data
Every field from FDA enforcement report D-0769-2016, exactly as published.
Show all FDA fields
- City
- Camarillo
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 73152
- Address
- 5187 Camino Ruiz
- Code information
- Lot #GS009075; Exp. 09/17 Lot #GS009763; Exp. 09/17 Lot #GS010178; Exp. 10/17
- Postal code
- 93012-8601
- Report date
- Mar 16, 2016
- Product type
- Drugs
- Recall number
- D-0769-2016
- Classification
- Class III
- Recalling firm
- Golden State Medical Supply Inc.
- Product quantity
- 172 100-count packages (17,200 tablets)
- Termination date
- Jun 28, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Atorvastatin Calcium 40 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-325-77
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 27, 2016
- Initial firm notification
- Letter
- Center classification date
- Mar 9, 2016