CLASS II Drug recall · Reported 9 Nov 2016 · FDA Enforcement Report
Succinylcholine Chloride, 20 mg per mL, 200 mg per vials recalled
Pharmedium Services is recalling Succinylcholine Chloride, 20 mg per mL, 200 mg per vials, distributed nationwide in the US. The recall was initiated on 12 Oct 2016 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-0125-2017
- FDA event ID
- 75567
- Recalling firm
- Pharmedium Services, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Oct 2016
- FDA classified
- 3 Nov 2016
- Reported
- 9 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Oct 2016 | Recall initiated by company | |
| 3 Nov 2016 | Classified by FDA | +22 days |
| 9 Nov 2016 | 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 Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
Where it was distributed
Nationwide
Questions about this recall
Is Succinylcholine Chloride, 20 mg per mL, 200 mg per vials recalled?
Yes. Pharmedium Services recalled Succinylcholine Chloride, 20 mg per mL, 200 mg per vials on 12 Oct 2016. The recall is Class II and its status is Terminated. Recall number D-0125-2017.
Why was it recalled?
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
Which lots are affected?
Lot #: 162790012M, Exp. 1/3/2017
Where was it sold?
Nationwide
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.
More recalls from Pharmedium Services
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|---|---|---|---|---|---|
| Drug | CLASS II | rocuronium Bromide, 10 mg per mL, 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | ePHEDrine Sulfate, 5 mg per mL, 25 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
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| Drug | CLASS II | nICARdipine HCl 1 mg/mL) 1 mg recalled by PharMEDium Services | PharMEDium Services | Sterility | Nationwide |
| Drug | CLASS II | rocuronium Bromide 10 mg per mL 50 mg per BD Syringe recalled | PharMEDium Services | Sterility | Nationwide |