CLASS II Drug recall · Reported 18 Nov 2015 · FDA Enforcement Report
PGE 30mcg/ml Injection vials, Rx recalled by Pacific Healthcare
Pacific Healthcare is recalling PGE 30mcg/ml Injection vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA, distributed in California, New Jersey. The recall was initiated on 7 Oct 2015 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-0177-2016
- FDA event ID
- 72361
- Recalling firm
- Pacific Healthcare, Bellflower, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Oct 2015
- FDA classified
- 10 Nov 2015
- Reported
- 18 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 7 Oct 2015 | Recall initiated by company | |
| 10 Nov 2015 | Classified by FDA | +34 days |
| 18 Nov 2015 | Published in enforcement report | +8 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; FDA inspection identified GMP violations potentially impacting product quality and 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
PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Where it was distributed
CA and NJ
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Which lots are affected?
07062015@8, exp 1/2/2016; 07162015@7, exp 1/12/2016; 07272015@5, exp 1/23/2016; 08142015@9, exp 2/10/2016
Where was it sold?
CA and NJ
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 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.
Other products in this recall event
15 other products · FDA event 72361This product is part of a recall event; the main page for the event is Papa/PGE1/Phento (30mg/10mg/1mg/ml) Injection and vials, Rx recalled.
More recalls from Pacific Healthcare
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nandrolone 200 mg/ml Injection and vials, Rx recalled | Pacific Healthcare | Sterility | CA, NJ |
| Drug | CLASS II | Papa/PGE1/Phento (30mg/50mcg/0.5mg/ml), Injection vial, Rx recalled | Pacific Healthcare | Sterility | CA, NJ |
| Drug | CLASS II | Papa/PGE1/Phento (35mg/12mcg/1.5mg/ml), Injection vial, Rx recalled | Pacific Healthcare | Sterility | CA, NJ |
| Drug | CLASS II | Papa/PGE1/Phento (30mg/40mcg/1mg/ml) Injection vial, Rx recalled | Pacific Healthcare | Sterility | CA, NJ |
| Drug | CLASS II | Papa/PGE1/Phento (15mg/5mcg/0.5mg/ml) Injection and vials recalled | Pacific Healthcare | Sterility | CA, NJ |
Other Pge recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PGE 20mcg/ml Injection vial, Rx, B & B Health Mart Pharmacy recalled | Pacific Healthcare | Sterility | CA, NJ |
| Drug | CLASS II | PGE 25mcg/ml, Injection vial, Rx recalled by Pacific Healthcare | Pacific Healthcare | Sterility | CA, NJ |
| Drug | CLASS II | PGE 20 mcg/mL injectable recalled by Martin Avenue Pharmacy | Martin Avenue Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | PGE 20 mcg/mL Injectable, and PGE 40 mcg/mL recalled | Compounding Centre At Blue Ridge | Sterility | NC |