Why it was recalled
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Product description
Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.
Lot numbers, UPCs & expiration codes
Lot #: 0000115590, Expiry: 5/10/17; Lot #: 0000117563, Expiry: 5/10/17.
Where it was sold
Distributed in the US including: CA, IL & NC; Canada
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-0563-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 30, 2015
- FDA report date
- Jan 13, 2016
- Quantity
- 265 Drums
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Avantor Performance Materials Inc
Original FDA data
Every field from FDA enforcement report D-0563-2016, exactly as published.
Show all FDA fields
- City
- Center Valley
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 72818
- Address
- 3477 Corporate Parkway
- Code information
- Lot #: 0000115590, Expiry: 5/10/17; Lot #: 0000117563, Expiry: 5/10/17.
- Postal code
- 18034
- Report date
- Jan 13, 2016
- Product type
- Drugs
- Recall number
- D-0563-2016
- Classification
- Class III
- Recalling firm
- Avantor Performance Materials Inc
- Product quantity
- 265 Drums
- Termination date
- Dec 19, 2016
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.
- Distribution pattern
- Distributed in the US including: CA, IL & NC; Canada
- Recall initiation date
- Oct 30, 2015
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jan 6, 2016