CLASS II Drug recall · Reported 3 Jul 2019 · FDA Enforcement Report
ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites* recalled
Premier Pharmacy Labs is recalling ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites* in a Sterile SDV, distributed nationwide in the US. The recall was initiated on 18 Jun 2019 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-1413-2019
- FDA event ID
- 83146
- Recalling firm
- Premier Pharmacy Labs, Weeki Wachee, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jun 2019
- FDA classified
- 21 Jun 2019
- Reported
- 3 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Undeclared Sulfites
Timeline
| 18 Jun 2019 | Recall initiated by company | |
| 21 Jun 2019 | Classified by FDA | +3 days |
| 3 Jul 2019 | 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: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Product as listed by the FDA
ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites* in a Sterile SDV recalled?
Yes. Premier Pharmacy Labs recalled ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites* in a Sterile SDV on 18 Jun 2019. The recall is Class II and its status is Terminated. Recall number D-1413-2019.
Why was it recalled?
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Which lots are affected?
All lots remaining within expiry.
Where was it sold?
Nationwide in the USA
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 Premier Pharmacy Labs
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Naloxone HCL Preserved INJ, 500mg/ (10mg/mL) Sterile MDV recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Phenylephrine HCL PF INJ in 9% Sodium Chloride, 1000mcg recalled | Premier Pharmacy Labs | Undeclared Sulfites | Nationwide |
| Drug | CLASS II | Orphenadrine Citrate Sterile Injectable Solution *Contains recalled | Premier Pharmacy Labs | Undeclared Sulfites | Nationwide |
| Drug | CLASS II | Mitomycin Preservative Free Irrigation, 40mg/ (4mg/mL) SDV recalled | Premier Pharmacy Labs | Sterility | Nationwide |
| Drug | CLASS II | Riboflavin 5-Phosphate Sodium Ophthalmic Solution recalled | Premier Pharmacy Labs | Sterility | Nationwide |