The Recall Desk
SevereFDA (Drugs)·D-0302-2022·Announced 2022-01-05

dilTIAZem HCl Injection Recalled Due to Sterility Assurance Failure

SterRx is recalling dilTIAZem HCl 125 mg per 125 mL injectable solution nationwide due to lack of assurance of sterility. The recall affects 24,300 bags distributed across the United States.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this as a Class II recall. Lack of sterility assurance in an injectable pharmaceutical product presents a serious risk of infection or other adverse effects in patients receiving intravenous medication, warranting a Severe classification.

Plain-English summary

SterRx, LLC is recalling dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, an intravenous medication, due to lack of assurance of sterility. A total of 24,300 bags have been distributed nationwide.

The affected lots are: 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-Feb-22), and S21300/BYQ (19-Feb-22). The product is identified by NDC 70324-976-01.

Healthcare providers and patients who have received this medication should contact their healthcare provider to discuss potential risks and next steps. Patients should not stop taking prescribed medications without consulting their healthcare provider.

The recalled product

Product
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.
Manufacturer
SterRx, LLC
Category
Drug — Injectable / Intravenous
Hazard
Affected units
24,300

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 26 recalled by SterRx, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 26 products in this recall →

Related recalls

Same manufacturer · SterRx, LLC

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Same hazard · sterility failure

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