The Recall Desk
SevereFDA (Drugs)·D-1172-2019·Announced 2019-04-24

Anderson Compounding Pharmacy Recalls Prostaglandin Quad Vials Due to Sterility Concerns

Anderson Compounding Pharmacy is recalling Prostaglandin Quad with Atropine vials because the product lacks sterility assurance. The recall covers all lots distributed nationwide.

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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences (such as lack of sterility assurance in injectable medications) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.

Plain-English summary

Anderson Compounding Pharmacy, Inc. is recalling Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vials. The recall is being conducted because the product lacks sterility assurance. The recall covers all lots of the product, which was distributed nationwide.

The FDA has classified this recall as Class II. This classification indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Affected units
5

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 (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 68 recalled by Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy 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 68 products in this recall →

Same manufacturer · Anderson Compounding Pharmacy, Inc. DBA Anderson Compounding Pharmacy

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