CLASS II Drug recall · Reported 18 Nov 2015 · FDA Enforcement Report
Testosterone Cypionate 250 mg/mL Injection vial, Rx recalled
Pacific Healthcare is recalling Testosterone Cypionate 250 mg/mL Injection vial, Rx, B & B Health Mart Pharmacy, 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-0167-2016
- 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
Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA
Where it was distributed
CA and NJ
Questions about this recall
Is Testosterone Cypionate 250 mg/mL Injection vial, Rx, B & B Health Mart Pharmacy recalled?
Yes. Pacific Healthcare recalled Testosterone Cypionate 250 mg/mL Injection vial, Rx, B & B Health Mart Pharmacy on 7 Oct 2015. The recall is Class II and its status is Terminated. Recall number D-0167-2016.
Why was it recalled?
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Which lots are affected?
07282015@7, exp 10/26/2015, 07292015@6, 10/27/2015, 08252015@4, 11/23/2015
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 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 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 |