CLASS II Drug recall · Reported 16 Mar 2016 · FDA Enforcement Report
Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 2 mg/ml, vol recalled
Hartley Medical Center Pharmacy, Incorporated is recalling Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 2 mg/ml, vol, distributed nationwide in the US. The recall was initiated on 4 Feb 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-0760-2016
- FDA event ID
- 73304
- Recalling firm
- Hartley Medical Center Pharmacy, Incorporated, Long Beach, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Feb 2016
- FDA classified
- 4 Mar 2016
- Reported
- 16 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 4 Feb 2016 | Recall initiated by company | |
| 4 Mar 2016 | Classified by FDA | +29 days |
| 16 Mar 2016 | Published in enforcement report | +12 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 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
Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 11.2 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Where it was distributed
Nationwide. No foreign distribution.
Questions about this recall
Is Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 2 mg/ml, vol recalled?
Yes. Hartley Medical Center Pharmacy, Incorporated recalled Hydromorphone HCL 7 mg/ml/Bupivacaine HCL 2 mg/ml, vol on 4 Feb 2016. The recall is Class II and its status is Terminated. Recall number D-0760-2016.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
BUD: 5/3/2016
Where was it sold?
Nationwide. No foreign distribution.
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.