The Recall Desk
SevereFDA (Drugs)·D-1369-2012·Announced 2012-06-20

Meridian Recalls Diazepam Autoinjectors Due to High Carbostyril Levels

Meridian Medical Technologies is recalling 83,400 Diazepam autoinjectors because they contain high levels of carbostyril, a known degradation product.

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 classified this recall as Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant quality deviations like high out-of-specification degradation products.

Plain-English summary

Meridian Medical Technologies, a Pfizer Company, is recalling 83,400 units of Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use. The recall is being conducted because the product contains high out-of-specification levels of carbostyril, which is a known degradation product of diazepam.

The affected product is distributed nationwide, as well as in military settings, Italy, Singapore, Sweden, and Canada. The specific lots involved are 8D1082 (expiration 01/13) and 8D1151 (expiration 03/13). The product is identified by NDC 11704-600-01 and NSN 6505-01-274-0951.

Consumers and healthcare providers should stop using the affected autoinjectors and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
DIAZEPAM (DIAZEPAM)
Brand
DIAZEPAM
Affected units
83,400

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 (4)

  • Lot #: 8D1082
  • Exp 01/13
  • 8D1151
  • Exp 03/13

UPCs (1)

  • 0311704600015

Distribution

Distributed nationwide across the United States.

Same manufacturer · Meridian Medical Technologies a Pfizer Company

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