Agency classClass IIOur severity:Severe FDA (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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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: sterility-failure
infection-risk
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 →

Same manufacturer · SterRx, LLC

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