SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94
Reported: August 12, 2015 Initiated: June 26, 2015 #D-1312-2015
Product Description
SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94
Reason for Recall
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Details
- Recalling Firm
- The Apothecary Shoppe LLC
- Units Affected
- 40 mL
- Distribution
- Oklahoma
- Location
- Tulsa, OK
Frequently Asked Questions
What product was recalled? ▼
SO-Acetylcysteine 10% Sterile Ophthalmic Solution, Rx Only, 10 mL bottle, Apothecary Shoppe, Compounding Pharmacy, Tulsa, OK 74135, NDC 13452-2774-94. Recalled by The Apothecary Shoppe LLC. Units affected: 40 mL.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 12, 2015. Severity: Moderate. Recall number: D-1312-2015.
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