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Class II: temporary or reversible health riskTerminated

Medicap Pharmacy Acetylcyst 10% OPHT SOL Recall

Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry La…

Medicap Pharmacy · Meridian, ID

Risk level
Class II
Reported by FDA
Aug 3, 2016
Recall ID
D-1447-2016
Check your lot numberHow we source this data

Summary

Medicap Pharmacy recalled Acetylcyst 10% OPHT SOL starting Jul 7, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1447-2016 on Aug 3, 2016. Reason: Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.

Product description

Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.

Lot numbers, UPCs & expiration codes

Lot #: 05092016@19, Beyond Use Date: 06/08/16; Discard After 09/01/2017.

Where it was sold

ID

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1447-2016
Classification
Class II
Status
Terminated
Recall initiated
Jul 7, 2016
FDA report date
Aug 3, 2016
Quantity
1 bottle
Recall type
Voluntary: Firm initiated
Recalling firm
Medicap Pharmacy

Original FDA data

Every field from FDA enforcement report D-1447-2016, exactly as published.

Show all FDA fields
City
Meridian
State
ID
Status
Terminated
Country
United States
Event ID
74725
Address
2790 W Cherry Ln Ste 100
Code information
Lot #: 05092016@19, Beyond Use Date: 06/08/16; Discard After 09/01/2017.
Postal code
83642-1102
Report date
Aug 3, 2016
Product type
Drugs
Recall number
D-1447-2016
Classification
Class II
Recalling firm
Medicap Pharmacy
Product quantity
1 bottle
Termination date
Aug 8, 2016
Reason for recall
Lack of Assurance of Sterility: Sterile products were not produced in a controlled, sterile environment.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
Distribution pattern
ID
Recall initiation date
Jul 7, 2016
Initial firm notification
Letter
Center classification date
Jul 22, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1447-2016, published Aug 3, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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