CLASS III Drug recall · Reported 13 Jan 2016 · FDA Enforcement Report
Magnesium Sulfate 7-Hydrate recalled by Avantor Performance Materials
Avantor Performance Materials is recalling Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, Avantor Performance, distributed in California, Illinois, North Carolina. The recall was initiated on 30 Oct 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0563-2016
- FDA event ID
- 72818
- Recalling firm
- Avantor Performance Materials, Center Valley, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Oct 2015
- FDA classified
- 6 Jan 2016
- Reported
- 13 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
Timeline
| 30 Oct 2015 | Recall initiated by company | |
| 6 Jan 2016 | Classified by FDA | +68 days |
| 13 Jan 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Distributed in the US including: CA, IL & NC; Canada
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: Out of specifications results for impurities.
Which lots are affected?
Lot #: 0000115590, Expiry: 5/10/17; Lot #: 0000117563, Expiry: 5/10/17.
Where was it sold?
Distributed in the US including: CA, IL & NC; Canada
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Avantor Performance Materials
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Magnesium Chloride, 6-Hydrate, Crystal recalled | Avantor Performance Materials | Potency & Assay | Nationwide |
| Drug | CLASS II | Potassium Phosphate, Monobasic, Crystal, NF recalled | Avantor Performance Materials | Potency & Assay | Nationwide |