CLASS II Drug recall · Reported 5 Jan 2022 · FDA Enforcement Report
dilTIAZem HCl 125 mg per (1 mg per mL) recalled by SterRx
SterRx is recalling dilTIAZem HCl 125 mg per (1 mg per mL) in 0.7% Sodium Chloride Injection, distributed nationwide in the US. The recall was initiated on 12 Nov 2021 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-0302-2022
- FDA event ID
- 89059
- Recalling firm
- SterRx, Plattsburgh, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Nov 2021
- FDA classified
- 29 Dec 2021
- Reported
- 5 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Blood Pressure Medication
Timeline
| 12 Nov 2021 | Recall initiated by company | |
| 29 Dec 2021 | Classified by FDA | +47 days |
| 5 Jan 2022 | 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
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
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lots S21164/BTV, 3-Dec-21; S21191/BUU, 18-DEC-21; S21197/BUZ, 31-Dec-21; S21220/BVV, 13-Jan-22; S21271/BX0, 27-Jan-22; S21272/BXP, 28-Jan-22; S21299/BYP, 18-Fev-22; S21300/BYQ, 19-Feb-22
Where was it sold?
U.S.A. Nationwide
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
25 other products · FDA event 89059This product is part of a recall event; the main page for the event is Morphine Sulfate, in 0.9% Sodium Chloride Injection recalled by SterRx.
More recalls from SterRx
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Norepinephrine 32 mg per (128 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 8 mg per (32 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 16 mg per (64 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 4 mg per (16 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |