CLASS II Drug recall · Reported 24 Feb 2016 · FDA Enforcement Report
papaverine prostaglandin 30 mg/30 mcg/mL unit size recalled
Abbott's Compounding Pharmacy is recalling papaverine prostaglandin 30 mg/30 mcg/mL unit size, refrigerate, This Rx is Compounded, distributed in California. The recall was initiated on 15 Jan 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-0688-2016
- FDA event ID
- 73090
- Recalling firm
- Abbott's Compounding Pharmacy, Berkeley, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jan 2016
- FDA classified
- 17 Feb 2016
- Reported
- 24 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 15 Jan 2016 | Recall initiated by company | |
| 17 Feb 2016 | Classified by FDA | +33 days |
| 24 Feb 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
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
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
papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705
Where it was distributed
CA
Questions about this recall
Is papaverine prostaglandin 30 mg/30 mcg/mL unit size, refrigerate, This Rx is Compounded recalled?
Yes. Abbott's Compounding Pharmacy recalled papaverine prostaglandin 30 mg/30 mcg/mL unit size, refrigerate, This Rx is Compounded on 15 Jan 2016. The recall is Class II and its status is Terminated. Recall number D-0688-2016.
Why was it recalled?
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Which lots are affected?
All lots
Where was it sold?
CA
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.