CLASS II Drug recall · Reported 16 May 2018 · FDA Enforcement Report
Glatiramer Acetate 40 mg/mL recalled by Kroger Specialty Pharmacy
Kroger Specialty Pharmacy is recalling Glatiramer Acetate 40 mg/mL, distributed in Arkansas, Florida, Illinois, Louisiana, Mississippi. The recall was initiated on 3 Apr 2018 and the FDA has classified it as Class II.
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-0778-2018
- FDA event ID
- 79748
- Recalling firm
- Kroger Specialty Pharmacy, Vicksburg, MS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Apr 2018
- FDA classified
- 10 May 2018
- Reported
- 16 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 3 Apr 2018 | Recall initiated by company | |
| 10 May 2018 | Classified by FDA | +37 days |
| 16 May 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Processing Controls.
Product as listed by the FDA
Glatiramer Acetate 40 mg/mL NDC 00378-6961-12 28 days supply
Where it was distributed
MS, LA, AR, IL, FL
ArkansasFloridaIllinoisLouisianaMississippi
Stores named: Kroger
Questions about this recall
Is Glatiramer Acetate 40 mg/mL recalled?
Yes. Kroger Specialty Pharmacy recalled Glatiramer Acetate 40 mg/mL on 3 Apr 2018. The recall is Class II and its status is Terminated. Recall number D-0778-2018.
Why was it recalled?
Lack of Processing Controls.
Which lots are affected?
All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
Where was it sold?
MS, LA, AR, IL, FL
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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