Why it was recalled
Microbial Contamination of Non-Sterile Products
Product description
FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING
Lot numbers, UPCs & expiration codes
Bulk Product Batch # ( Packaged Lot#) a) S55350 Exp. 20 APR 2018, S55378 Exp. 07 MAR 2018, S55386 Exp. 14 MAR 2018, S53284 Exp.14 FEB 2018, S53283 Exp. 10 FEB 2018; b) S53287 Exp. 16 FEB 2018, S33417 Exp. 03 FEB 2018; c) S33445 Exp. 17 FEB 2018, S33452 Exp. 24 FEB 2018; d) S33397 Exp. 07 FEB 2018
Where it was sold
Germany; products were packaged at the Pfizer Manufacturing Deutshland Gmbh location and then distributed to other countries. No product distributed in the United States or its territories.
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-0212-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 27, 2017
- FDA report date
- Jan 17, 2018
- Quantity
- a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Manufacturing Deutschland GmbH
Original FDA data
Every field from FDA enforcement report D-0212-2018, exactly as published.
Show all FDA fields
- City
- Freiburg im Breisgau
- Status
- Terminated
- Country
- Germany
- Event ID
- 78682
- Address
- Pfizer GmbH Arzneimittelwerk Godecke
- Address (line 2)
- (Betriebsstatte Freiburg)
- Code information
- Bulk Product Batch # ( Packaged Lot#) a) S55350 Exp. 20 APR 2018, S55378 Exp. 07 MAR 2018, S55386 Exp. 14 MAR 2018, S53284 Exp.14 FEB 2018, S53283 Exp. 10 FEB 2018; b) S53287 Exp. 16 FEB 2018, S33417 Exp. 03 FEB 2018; c) S33445 Exp. 17 FEB 2018, S33452 Exp. 24 FEB 2018; d) S33397 Exp. 07 FEB 2018
- Report date
- Jan 17, 2018
- Product type
- Drugs
- Recall number
- D-0212-2018
- Classification
- Class II
- Recalling firm
- Pfizer Manufacturing Deutschland GmbH
- Product quantity
- a)7387263 tablets; b)5877188 tablets; c)11755825 tablets; d) 5872816 tablets
- Termination date
- May 11, 2020
- Reason for recall
- Microbial Contamination of Non-Sterile Products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg SMT G EP PR KR, FOR MANUFACTURING, PROCESSING OR REPACKAGING
- Distribution pattern
- Germany; products were packaged at the Pfizer Manufacturing Deutshland Gmbh location and then distributed to other countries. No product distributed in the United States or its territories.
- Recall initiation date
- Sep 27, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 8, 2018